Medical device recalls: May 2018

The FDA posted 161 medical device recall records in May 2018, from 25 recall events by 24 companies. 42 are Class I, the most serious category.

Each product in a recall gets its own record, so one recall event can cover several records. What recall classes mean.

Companies with the most recall events

Smith & Nephew, Inc. · 2 events, 3 records
Covidien Medtronic · 1 event, 40 records
Vyaire Medical · 1 event, 35 records, 35 Class I
Siemens Healthcare Diagnostics, Inc. · 1 event, 24 records
Boston Scientific Corporation · 1 event, 11 records
Philips Medical Systems Nederlands · 1 event, 7 records
Cook Inc. · 1 event, 6 records
Baxter Healthcare Corporation · 1 event, 5 records

FDA root cause

Process control · 50
Component design/selection · 35
Error in labeling · 24
Device Design · 21
Equipment maintenance · 9
Nonconforming Material/Component · 8
Software design · 5
Employee error · 5

Class I recalls (42)

The most serious: a reasonable probability that using the device will cause serious health problems or death.

Heartware Medtronic HVAD System for cardiac use. Including the following parts:Class I
Z-1903-2018 · Heartware · posted May 21, 2018 · Open, Classified
Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the power source is connected, that may cause unintended switching to the secondary power source and/or…
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3Class I
Z-1774-2018 · Abbott · posted May 17, 2018 · Terminated
Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and…
MindFrame Capture LP Revascularization Devices: Product Numbers:Class I
Z-1701-2018 · Micro Therapeutics Inc, Dba Ev3 Neurovascular · posted May 16, 2018 · Terminated
There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag ↗Class I
Z-1547-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector ↗Class I
Z-1548-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, manometer ↗Class I
Z-1549-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter ↗Class I
Z-1550-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer ↗Class I
Z-1551-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs ↗Class I
Z-1552-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filter ↗Class I
Z-1553-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve ↗Class I
Z-1554-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, filter ↗Class I
Z-1555-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer ↗Class I
Z-1556-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor ↗Class I
Z-1557-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor,… ↗Class I
Z-1558-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor, monometer ↗Class I
Z-1559-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow ↗Class I
Z-1560-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Infant, with mask, 40 inch oxygen reservoir tubing, pressure-relief valve, CO2 detector,… ↗Class I
Z-1561-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing ↗Class I
Z-1562-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Pediatric, with mask, 28inch large bore tubing, pressure-relief valve ↗Class I
Z-1563-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve ↗Class I
Z-1564-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve ↗Class I
Z-1565-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve ↗Class I
Z-1566-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Adult, with mask, 28inch large bore tubing, pressure-relief valve ↗Class I
Z-1567-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve ↗Class I
Z-1568-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve ↗Class I
Z-1569-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve ↗Class I
Z-1570-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, PEEP valve ↗Class I
Z-1571-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve ↗Class I
Z-1572-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve ↗Class I
Z-1573-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve ↗Class I
Z-1574-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP valve ↗Class I
Z-1575-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow ↗Class I
Z-1576-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Broselow Hinkle Kit ↗Class I
Z-1577-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Broselow Hinkle Kit ↗Class I
Z-1578-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Replacement kit for outer shell, Broselow ↗Class I
Z-1579-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, manometer, PEEP valve ↗Class I
Z-1580-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve, PEEP valve ↗Class I
Z-1581-2018 · Vyaire Medical · posted May 10, 2018 · Terminated
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the mask from the elbow of the resuscitator.
Fabius MRI, anesthesia machine, catalog no. 8607300Class I
Z-1481-2018 · Draeger Medical, Inc. · posted May 8, 2018 · Terminated
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
Fabius GS Premium, anesthesia machine, catalog no. 8607000 ↗Class I
Z-1482-2018 · Draeger Medical, Inc. · posted May 8, 2018 · Terminated
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
Fabius Tiro, anesthesia machine, catalog no. 8606000 ↗Class I
Z-1483-2018 · Draeger Medical, Inc. · posted May 8, 2018 · Terminated
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
Fabius Tiro M, anesthesia machine, catalog no. 8608400 ↗Class I
Z-1484-2018 · Draeger Medical, Inc. · posted May 8, 2018 · Terminated
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.

Class II recalls (119)

The device may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Respire Pink Series EF+ Oral Sleep Apnea Device.Class II
Z-1947-2018 · Respire Medical · posted May 29, 2018 · Terminated
Potential for device breakage during use
Respire Pink+ Hard/Soft Oral Sleep Apnea DeviceClass II
Z-1948-2018 · Respire Medical · posted May 29, 2018 · Terminated
Potential for device breakage during use
Respire Pink+ Hard Oral Sleep Apnea DeviceClass II
Z-1949-2018 · Respire Medical · posted May 29, 2018 · Terminated
Potential for device breakage during use
Respire Pink H/S Oral Sleep Apnea Device ↗Class II
Z-1950-2018 · Respire Medical · posted May 29, 2018 · Terminated
Potential for device breakage during use
Respire Pink H/S Oral Sleep Apnea Device ↗Class II
Z-1951-2018 · Respire Medical · posted May 29, 2018 · Terminated
Potential for device breakage during use
MicroAire SmartRelease Endoscopic System, Endoscopic Carpal Tunnel Release, SmartRelease Handpiece, containing IFU… ↗Class II
Z-2107-2018 · MicroAire Surgical Instruments, LLC · posted May 25, 2018 · Terminated
The Instructions for Use (IFU) is incorrect with regards to sterilization parameters and must be replaced.
Birmingham Hip Resurfacing Femoral Head:Class II
Z-2267-2018 · Smith & Nephew, Inc. · posted May 21, 2018 · Terminated
The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the…
Birmingham Hip Resurfacing Acetabular Cup with Impactor:Class II
Z-2268-2018 · Smith & Nephew, Inc. · posted May 21, 2018 · Terminated
The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the…
Sorin Stockert Heater-Cooler System 3T, ↗Class II
Z-1901-2018 · LivaNova USA · posted May 18, 2018 · Terminated
Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm.
Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. ↗Class II
Z-1891-2018 · Volcano Corporation · posted May 17, 2018 · Terminated
The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and results in an overly bright IVUS Image.
Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm- 2.0mm ( Item Code 030450)Class II
Z-1814-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 2.5mm ( Item Code 030451)Class II
Z-1815-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Endo GIA" Auto Suture" Universal Articulating Loading Unit 30mm - 3.5mm ( Item Code 030452)Class II
Z-1816-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm - 2.5mm( Item Code 030454)Class II
Z-1817-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Endo GIA" Auto Suture" Universal Articulating Loading Unit 45mm- 3.5mm( Item Code 030455)Class II
Z-1818-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm -2.5mm ( Item Code 030457)Class II
Z-1819-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458)Class II
Z-1820-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30CTAV)Class II
Z-1821-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Endo GIA" 30mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA30AV)Class II
Z-1822-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Endo GIA" 45mm Gray Curved Tip Articulating Vascular Reload with Tri-Staple" Technology( Item Code EGIA45CTAV)Class II
Z-1823-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" DevicesClass II
Z-1824-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
BOX KIT1095V KIT OBESITAS (Item Code KIT1095V)Class II
Z-1825-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
1) BOX 01KBAR006116V PROC BYPASS 01KBAR0061(Item Code 01KBAR006116V PROC BYPAS)Class II
Z-1826-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
BOX1073076GASB1 BBR GASTRIC BYPASS S(Item Code BOX1073076GASB1 BBR GASTRIC BYPASS S)Class II
Z-1828-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
1) BOX BOX1073180 APPE1 APPENDIX KIT ZAMSClass II
Z-1829-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
1)BOX HEMIGX1 ZESTAW DO HEMICOLECTOMIIClass II
Z-1830-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
KIT00486R OBESIDAD D. WORWARLD 2 X1Class II
Z-1831-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
BOX KIT00713 KIT BY PASSClass II
Z-1832-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
BOX KIT00714 KIT SLEEVEClass II
Z-1833-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
BOX KIT1171C KIT LAP CYSTECTOMYClass II
Z-1834-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
KIT-DE-0080 BYPASS KIT LOHNE X1( Item KIT-DE-0080)Class II
Z-1837-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
1)KIT4184 APEN LOBECTOMY KIT X0Class II
Z-1838-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
BOX KITDE0108 BYPASS KIT LUEBECK ( KITDE0108)Class II
Z-1839-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
1) BOX KITDE0143 BYPASS BOX (Item Number: KITDE0143,Class II
Z-1840-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
1)BOX KITDE0183 APPENDIX LIPPE DETMOLD (KITDE0183)Class II
Z-1842-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
1)LAPBARLECZNA ZESTAW BARIATRYCZNY LECZNAClass II
Z-1843-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
BOX LAPIMBGP1 ZESTAW DO MGBP (LAPIMBGP1)Class II
Z-1844-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
1) BOX LAPZD ZESTAW DO SGClass II
Z-1847-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
BOX MGBGLOGX1 ZESTAW MINI GASTRIC BYPASSClass II
Z-1848-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
1)BOX PST01199 BARIATRIC TRISTAPLE (Item Number: PST01199)Class II
Z-1849-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
MGBX ZESTAW GB LS X1Class II
Z-1850-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
BOX PST03533 KIT APP STAPLERClass II
Z-1852-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
BOX PST03699 KIT APP MED ALTERNATIV STAPClass II
Z-1854-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
1)BOX PST04089 SLEEVE AIWA CLINICClass II
Z-1855-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
SLEEVEGK1 ZESTAW DO ZABIEGOW SLEEVEX1Class II
Z-1858-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
1)BOX SLEEVEGK3Class II
Z-1859-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
BOX TGGLOGOWX1 DO TOTAL GASTRECTOMIIIClass II
Z-1862-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
BOX VATS1SCDX DO ZABIEGOW VATSClass II
Z-1863-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
BOX VMIN ZESTAW DO VATS PODSTAWOWYClass II
Z-1865-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
BOX VWR ZESTAW DO VATS KLINClass II
Z-1866-2018 · Covidien Medtronic · posted May 16, 2018 · Terminated
Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.
Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made… ↗Class II
Z-1883-2018 · Coltene Whaledent Inc · posted May 14, 2018 · Terminated
The products are labeled with an incorrect product number.
BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M.Class II
Z-1802-2018 · Bard Peripheral Vascular Inc · posted May 11, 2018 · Terminated
Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present…
BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014.Class II
Z-1803-2018 · Bard Peripheral Vascular Inc · posted May 11, 2018 · Terminated
Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present…
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM ↗Class II
Z-1751-2018 · Cook Inc. · posted May 9, 2018 · Terminated
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS ↗Class II
Z-1752-2018 · Cook Inc. · posted May 9, 2018 · Terminated
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-30-M-FM ↗Class II
Z-1753-2018 · Cook Inc. · posted May 9, 2018 · Terminated
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM ↗Class II
Z-1754-2018 · Cook Inc. · posted May 9, 2018 · Terminated
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM ↗Class II
Z-1755-2018 · Cook Inc. · posted May 9, 2018 · Terminated
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM ↗Class II
Z-1756-2018 · Cook Inc. · posted May 9, 2018 · Terminated
Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
Syngo.Via VB20A model 1049610 ↗Class II
Z-1778-2018 · Siemens Medical Solutions USA, Inc · posted May 9, 2018 · Terminated
Functionality in the report sections "Findings Information" and "Summary of Measured Findings" not functioning properly. The corrected values modified in the report are neither saved, nor printed, nor sent to the information system. The system will still…
smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.Class II
Z-1921-2018 · Smith & Nephew, Inc. · posted May 9, 2018 · Terminated
Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001,… ↗Class II
Z-2185-2018 · Roche Diabetes Care, Inc. · posted May 9, 2018 · Terminated
The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detected once inserted, or biased results, which may not be detectable. In the…
Accu-Chek Performa Test Strip, Blood glucose monitoring system, Catalog no. 07299702001 ↗Class II
Z-2186-2018 · Roche Diabetes Care, Inc. · posted May 9, 2018 · Terminated
The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur,…
Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 ↗Class II
Z-2187-2018 · Roche Diabetes Care, Inc. · posted May 9, 2018 · Terminated
The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur,…
BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*)Class II
Z-2428-2018 · bioMerieux, Inc. · posted May 9, 2018 · Terminated
Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS and mini VIDAS system due to a…
BioMerieux VIDAS System in combination with Quality Control VIDAS* (QCV*)Class II
Z-2429-2018 · bioMerieux, Inc. · posted May 9, 2018 · Terminated
Increase of events affecting performance regarding pump clogging and displacement of the color-coded SPR label (DOT). These performance issues could contribute to erroneous results for any assay performed on the VIDAS and mini VIDAS system due to a…
Lactosorb RapidFlap, bone plate, Model No. 915-0020Class II
Z-1705-2018 · Zimmer Biomet, Inc. · posted May 7, 2018 · Terminated
The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited…
Capio SLIM Suture Capturing Device, Model #M0068318250.Class II
Z-1616-2018 · Boston Scientific Corporation · posted May 4, 2018 · Terminated
Potential for Capio sutures to break and /or detach.
Capio SLIM Box 5, Model #M0068318261Class II
Z-1617-2018 · Boston Scientific Corporation · posted May 4, 2018 · Terminated
Potential for Capio sutures to break and /or detach.
Capio CLClass II
Z-1618-2018 · Boston Scientific Corporation · posted May 4, 2018 · Terminated
Potential for Capio sutures to break and /or detach.
Capio Open Access Box 4 (Capio OPC)Class II
Z-1619-2018 · Boston Scientific Corporation · posted May 4, 2018 · Terminated
Potential for Capio sutures to break and /or detach.
Capio Standard Box 4 (Capio PC)Class II
Z-1620-2018 · Boston Scientific Corporation · posted May 4, 2018 · Terminated
Potential for Capio sutures to break and /or detach.
Capio RPClass II
Z-1621-2018 · Boston Scientific Corporation · posted May 4, 2018 · Terminated
Potential for Capio sutures to break and /or detach.
Uphold LITE w/ Capio SLIMClass II
Z-1622-2018 · Boston Scientific Corporation · posted May 4, 2018 · Terminated
Potential for Capio sutures to break and /or detach.
Posterior LITE w/ Capio SLIM ↗Class II
Z-1623-2018 · Boston Scientific Corporation · posted May 4, 2018 · Terminated
Potential for Capio sutures to break and /or detach.
PFR Kit- Pinnacle, Anterior Apical ↗Class II
Z-1624-2018 · Boston Scientific Corporation · posted May 4, 2018 · Terminated
PFR Kit- Pinnacle, Posterior ↗Class II
Z-1625-2018 · Boston Scientific Corporation · posted May 4, 2018 · Terminated
Potential for Capio sutures to break and /or detach.
Uphold Vaginal Support System ↗Class II
Z-1626-2018 · Boston Scientific Corporation · posted May 4, 2018 · Terminated
Potential for Capio sutures to break and /or detach.
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX ↗Class II
Z-1663-2018 · Baxter Healthcare Corporation · posted May 4, 2018 · Terminated
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr…
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL ↗Class II
Z-1664-2018 · Baxter Healthcare Corporation · posted May 4, 2018 · Terminated
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr…
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR ↗Class II
Z-1665-2018 · Baxter Healthcare Corporation · posted May 4, 2018 · Terminated
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr…
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP ↗Class II
Z-1666-2018 · Baxter Healthcare Corporation · posted May 4, 2018 · Terminated
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr…
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE ↗Class II
Z-1667-2018 · Baxter Healthcare Corporation · posted May 4, 2018 · Terminated
Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr…
Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge ↗Class II
Z-1668-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at…
Dimension Free Thyroxine (FT4L) Flex reagent cartridge ↗Class II
Z-1669-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at…
Dimension Sirolimus (SIRO) Flex reagent cartridgeClass II
Z-1670-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
Dimension Vista Cardiac Troponin I (CTNI) Flex reagent cartridgeClass II
Z-1671-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridgeClass II
Z-1672-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridgeClass II
Z-1673-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at…
IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal KitClass II
Z-1674-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
IMMULITE 2000/IMMULITE 2000 XPi Anti HBc ↗Class II
Z-1675-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
IMMULITE 2000/IMMULITE 2000 XPi Folic Acid ↗Class II
Z-1676-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
IMMULITE /IMMULITE 1000 BR-MA (CA15-3)Class II
Z-1677-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
IMMULITE /IMMULITE 1000 CEA ↗Class II
Z-1678-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
IMMULITE 2000/IMMULITE 2000 XPi CEAClass II
Z-1679-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
IMMULITE /IMMULITE 1000 Gastrin ↗Class II
Z-1680-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
IMMULITE 2000/IMMULITE 2000 XPi Gastrin ↗Class II
Z-1681-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
IMMULITE /IMMULITE 1000 OM-MA (CA125) ↗Class II
Z-1682-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
IMMULITE 2000/IMMULITE 2000 XPi OM-MA (CA125) ↗Class II
Z-1683-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
IMMULITE /IMMULITE 1000 TG ↗Class II
Z-1684-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
IMMULITE 2000/IMMULITE 2000 XPi TGClass II
Z-1685-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
IMMULITE /IMMULITE 1000 Vitamin B12Class II
Z-1686-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
ADVIA Centaur CyclosporineClass II
Z-1687-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at…
ADVIA Centaur DHEA-SO4 ↗Class II
Z-1688-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at…
ADVIA Centaur Folate (FOL)Class II
Z-1689-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
ADVIA Centaur HBc IgM ↗Class II
Z-1690-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
IMMULITE 2000/IMMULITE 2000 XPi BR-MA (CA15-3)Class II
Z-1691-2018 · Siemens Healthcare Diagnostics, Inc. · posted May 4, 2018 · Terminated
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE…
MultiDim Eleva 708032 ↗Class II
Z-1603-2018 · Philips Medical Systems Nederlands · posted May 3, 2018 · Terminated
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
708033 URODiagnost ↗Class II
Z-1604-2018 · Philips Medical Systems Nederlands · posted May 3, 2018 · Terminated
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
MultiDiagnost Eleva 708036 ↗Class II
Z-1605-2018 · Philips Medical Systems Nederlands · posted May 3, 2018 · Terminated
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
Mutlidiagnost-Eleva with Flat Detector 708034 ↗Class II
Z-1606-2018 · Philips Medical Systems Nederlands · posted May 3, 2018 · Terminated
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 ↗Class II
Z-1607-2018 · Philips Medical Systems Nederlands · posted May 3, 2018 · Terminated
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
MultiDiagnostic-Eleva with Flat Detector 708038 ↗Class II
Z-1608-2018 · Philips Medical Systems Nederlands · posted May 3, 2018 · Terminated
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
MultiDiagnostic-Eleva with Flat Detector 708035 ↗Class II
Z-1609-2018 · Philips Medical Systems Nederlands · posted May 3, 2018 · Terminated
The fixation of the upper and lower tilt actuator, of the MD-Eleva system might break off and the table will start to rotate from 0 to + 90 I- 90 degree with high speed. This rotating movement cannot be stopped by the user.
cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692Class II
Z-1610-2018 · Roche Diagnostics Corporation · posted May 3, 2018 · Terminated
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Cobas b 221<4>Roche OMNI S4 systemClass II
Z-1611-2018 · Roche Diagnostics Corporation · posted May 3, 2018 · Terminated
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
cobas b 221<6>Roche OMNI S6 systemClass II
Z-1612-2018 · Roche Diagnostics Corporation · posted May 3, 2018 · Terminated
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
cobas b 221 AutoQC Module Complete ↗Class II
Z-1613-2018 · Roche Diagnostics Corporation · posted May 3, 2018 · Terminated
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523Class II
Z-1389-2018 · Stryker Medical Division of Stryker Corporation · posted May 1, 2018 · Terminated
The power load floor plates which hold the ambulance cot anchors in place during patient transport, may be broken.

Source: FDA Medical Device Recalls and FDA enforcement reports (recall class), via openFDA. Records are grouped by the date the FDA posted them. Methodology · Not medical advice.