Medical device recalls: December 2006
The FDA posted 113 medical device recall records in December 2006, from 50 recall events by 43 companies. 113 have not been classified yet.
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
- Terumo Cardiovascular Systems Corp · 6 events, 33 records
- Smiths Medical ASD, Inc. · 2 events, 3 records
- Advanced Medical Optics, Inc. · 2 events, 2 records
- Arrow International Inc · 1 event, 18 records
- Smith & Nephew, Inc. Endoscopy Division · 1 event, 4 records
- AGA Medical Corporation · 1 event, 3 records
- Dentsply Friadent Ceramed · 1 event, 3 records
- Draeger Medical, Inc. · 1 event, 3 records
FDA root cause
- Other · 107
- Process control · 2
- Equipment maintenance · 2
- Software design · 1
- Process design · 1
Not yet classified (113)
The FDA has posted these records but has not published a class for them yet.
- Z-0319-2007 · Rymed Technologies, Inc. · posted Dec 30, 2006 · Terminated
Weld failures on IV connector (area of female luer and spike body)
- Z-0320-2007 · Rymed Technologies, Inc. · posted Dec 30, 2006 · Terminated
Weld failures on IV connector (area of female luer and spike body)
- Z-0321-2007 · Rymed Technologies, Inc. · posted Dec 30, 2006 · Terminated
Weld failures on IV connector (area of female luer and spike body)
- Z-0322-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0323-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0325-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0326-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0327-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0328-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0329-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0330-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0331-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0332-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0333-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0334-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0335-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0336-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0337-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0440-2007 · Smith & Nephew, Inc. Endoscopy Division · posted Dec 30, 2006 · Terminated
Mis-packaging-product in the package may be a different size than indicated on the labeling.
- Z-0441-2007 · Smith & Nephew, Inc. Endoscopy Division · posted Dec 30, 2006 · Terminated
Mis-packaging-product in the package may be a different size than indicated on the labeling.
- Z-0442-2007 · Smith & Nephew, Inc. Endoscopy Division · posted Dec 30, 2006 · Terminated
Mis-packaging-product in the package may be a different size than indicated on the labeling.
- Z-0443-2007 · Smith & Nephew, Inc. Endoscopy Division · posted Dec 30, 2006 · Terminated
Mis-packaging-product in the package may be a different size than indicated on the labeling.
- Z-324-2007 · Terumo Cardiovascular Systems Corp · posted Dec 30, 2006 · Terminated
Device module(s) may fail to properly initialize during start up, thus resulting in that single module being inoperable and a red 'X' being displayed on the monitor screen.
- Z-0264-2007 · Royal Global Wholesale · posted Dec 29, 2006 · Terminated
Counterfeit Glucose Test Strips
- Z-0265-2007 · Royal Global Wholesale · posted Dec 29, 2006 · Terminated
Counterfeit Glucose Test Strips (manufacturer unknown)
- Z-0318-2007 · Edwards Lifesciences Corporation of Puerto Rico · posted Dec 29, 2006 · Terminated
Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.
- Z-0305-2007 · EMD Chemicals Inc · posted Dec 27, 2006 · Terminated
Due to loose caps, the SO2 levels dropped significantly from release levels causing the product not to perform properly.
- Z-0306-2007 · Terumo Cardiovascular Systems Corp · posted Dec 27, 2006 · Terminated
Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.
- Z-0307-2007 · Terumo Cardiovascular Systems Corp · posted Dec 27, 2006 · Terminated
Improperly adjusting the occlusion setting may result in a pump jam error and pump stoppage.
- Z-0308-2007 · Philips Medical Systems · posted Dec 27, 2006 · Terminated
Potential for shock treatment to be delayed or prevented due to board contamination that causes intermittent switch operation
- Z-0309-2007 · Endologix Inc · posted Dec 27, 2006 · Terminated
Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair.
- Z-0310-2007 · Endologix Inc · posted Dec 27, 2006 · Terminated
Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair.
- Z-0311-2007 · Terumo Cardiovascular Systems Corp · posted Dec 27, 2006 · Terminated
The battery status light on the front panel may not accurately reflect the actual status of the battery. The battery may contain more charge than indicated.
- Z-0312-2007 · Terumo Cardiovascular Systems Corp · posted Dec 27, 2006 · Terminated
The battery status light on the front panel may not accurately reflect the actual status of the battery. The battery may contain more charge than indicated.
- Z-0313-2007 · Stardental Division · posted Dec 27, 2006 · Terminated
End cap component can disassemble.
- Z-0314-2007 · Terumo Cardiovascular Systems Corp · posted Dec 27, 2006 · Terminated
The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.
- Z-0315-2007 · Terumo Cardiovascular Systems Corp · posted Dec 27, 2006 · Terminated
The gas system may fail calibration prior to use due to incorrect gas system flowmeter software.
- Z-0316-2007 · Whiteside Biomechanics · posted Dec 27, 2006 · Terminated
The soft tissue pin in the retractor can break off and become embedded in the tissue.
- Z-0317-2007 · Beckman Coulter Inc · posted Dec 27, 2006 · Terminated
The ratio parameter assignments (numerator and denominator) of a protocol may inadvertently change after the Parameter Selection Dialog box is accessed. Issue limited only to protocols utilizing the Ratio parameter such as LeukoSure and DNA Cell Cycle.
- Z-0255-2007 · AGA Medical Corporation · posted Dec 19, 2006 · Terminated
AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier. AGA has no…
- Z-0256-2007 · AGA Medical Corporation · posted Dec 19, 2006 · Terminated
AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier. AGA has no…
- Z-0257-2007 · AGA Medical Corporation · posted Dec 19, 2006 · Terminated
AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier. AGA has no…
- Z-0270-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0271-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0272-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0273-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0274-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0275-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0276-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0277-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0278-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0279-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0280-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0281-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0282-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0283-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0284-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0285-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0286-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0287-2007 · Arrow International Inc · posted Dec 19, 2006 · Terminated
Catheter has separated from the infusion port body.
- Z-0289-2007 · Kavo America Corporation · posted Dec 19, 2006 · Terminated
The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could…
- Z-0290-2007 · Medtronic Neurological · posted Dec 19, 2006 · Terminated
A subset of Kinetra implantable neurostimulators may experience a failure of wire connections between the electronic hybrid circuit and battery which may lead to sudden cessation of therapy. Sudden cessation of therapy can result in the immediate return…
- Z-0291-2007 · Datex - Ohmeda, Inc · posted Dec 19, 2006 · Terminated
Certain Compact Absorbers may have an increased resistance to gas flow due to an improperly manufactured foam filter. The increased resistance can cause an elevated pressure at the ventilator end of the inspiratory circuit, but the pressure at the patient…
- Z-0294-2007 · Terumo Cardiovascular Systems Corp · posted Dec 19, 2006 · Terminated
The flow meter could malfunction resulting in loss of touchscreen control of the gas system, but the alternate mechanical control will remain operable.
- Z-0295-2007 · Medtronic Emergency Response Systems, Inc. · posted Dec 19, 2006 · Terminated
LIFEPAK 20 may lock-up when attempting to power-up on DC within 2 seconds after removing AC power.
- Z-0296-2007 · St Jude Medical CRMD · posted Dec 19, 2006 · Terminated
St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement…
- Z-0297-2007 · St Jude Medical CRMD · posted Dec 19, 2006 · Terminated
St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement…
- Z-0298-2007 · St Jude Medical CRMD · posted Dec 19, 2006 · Terminated
St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement…
- Z-0300-2007 · Smiths Medical PM, Inc. · posted Dec 19, 2006 · Terminated
An error occurred at the board manufacturing site which may affect the following parameters: - An electrical noise observed on the SpO2 pleth waveform generating and displaying erratic heart rates. % SpO2 reading displays dashes. - The ECG waveform may…
- Z-0301-2007 · Draeger Medical, Inc. · posted Dec 19, 2006 · Terminated
Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.
- Z-0302-2007 · Draeger Medical, Inc. · posted Dec 19, 2006 · Terminated
Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.
- Z-0303-2007 · Draeger Medical, Inc. · posted Dec 19, 2006 · Terminated
Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.
- Z-0304-2007 · Varian Medical Systems Inc · posted Dec 19, 2006 · Terminated
Selecting an empty space next to the ''Override'' or ''Acquire Actual'' buttons may result in mistreatment to the patient.
- Z-0261-2007 · Medical Plastics Devices Inc · posted Dec 16, 2006 · Terminated
Counterfeit Glucose Test Strips (manufacturer unknown)
- Z-0262-2007 · Medical Plastics Devices Inc · posted Dec 16, 2006 · Terminated
Counterfeit Glucose Test Strips (manufacturer unknown)
- Z-0263-2007 · Milwaukee Notions, Inc · posted Dec 16, 2006 · Terminated
Counterfeit (manufacturer unknown)
- Z-0269-2007 · Guidant Corporation · posted Dec 16, 2006 · Terminated
Shock Effectiveness: there is a potential for malfunction of a high voltage wire, which could compromise effectiveness of shock therapy. While no energy is lost, defibrillation thresholds may be higher (and safety margin may be reduced) because the…
- Z-0288-2007 · Mallinckrodt Inc · posted Dec 16, 2006 · Terminated
The flow rate programmed on the console may be changed without automatically updating the flow rate programmed on the power head. The injector will always inject in accordance with the parameters shown on the power head. If this lack of synchronization…
- Z-0258-2007 · Medrad Inc · posted Dec 15, 2006 · Terminated
Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive…
- Z-0259-2007 · Medrad Inc · posted Dec 15, 2006 · Terminated
Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive…
- Z-0148-2007 · Advanced Medical Optics, Inc. · posted Dec 14, 2006 · Terminated
The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters.
- Z-0254-2007 · Stryker Biotech · posted Dec 14, 2006 · Terminated
Lack of Labeling Precautions. Calstrux should not be used in combination with other products and the volume used should approximate the size of the defect. Adverse reactions have been reported with over filling the defect site or combination product…
- Z-0267-2007 · Advanced Medical Optics, Inc. · posted Dec 14, 2006 · Terminated
These specific serial numbers of lenses are being recalled because AMO has received reports of post-implantation cloudiness related to some lenses contained in this grouping.
- Z-0268-2007 · Medline Industries Inc · posted Dec 14, 2006 · Terminated
The product, labeled as sterile, had not gone through the sterilization process at the time of shipment.
- Z-0207-2007 · Medishop USA · posted Dec 8, 2006 · Terminated
Counterfeit-(manufacturer unknown)
- Z-0217-2007 · Biogenex Laboratories · posted Dec 8, 2006 · Terminated
Mislabeling: The product's "contents section " labeling (outer box) is mislabeled incorrectly printed as '1 x 100 mL Alk Phos Label' which should read '1 x 100 mL HRP Label'. A second, smaller label, incorrectly reads "RTU MultiLink HPR/AEC" which…
- Z-0233-2007 · Terumo Cardiovascular Systems Corp · posted Dec 7, 2006 · Terminated
The hand crank handle may separate and detach from the unit during use.
- Z-0234-2007 · Terumo Cardiovascular Systems Corp · posted Dec 7, 2006 · Terminated
The hand crank handle may separate and detach from the unit during use.
- Z-0235-2007 · Terumo Cardiovascular Systems Corp · posted Dec 7, 2006 · Terminated
The hand crank handle may separate and detach from the unit during use.
- Z-0236-2007 · Terumo Cardiovascular Systems Corp · posted Dec 7, 2006 · Terminated
The hand crank handle may separate and detach from the unit during use.
- Z-0237-2007 · Terumo Cardiovascular Systems Corp · posted Dec 7, 2006 · Terminated
The hand crank handle may separate and detach from the unit during use.
- Z-0238-2007 · Terumo Cardiovascular Systems Corp · posted Dec 7, 2006 · Terminated
The hand crank handle may separate and detach from the unit during use.
- Z-0239-2007 · Terumo Cardiovascular Systems Corp · posted Dec 7, 2006 · Terminated
The hand crank handle may separate and detach from the unit during use.
- Z-0240-2007 · Terumo Cardiovascular Systems Corp · posted Dec 7, 2006 · Terminated
The hand crank handle may separate and detach from the unit during use.
- Z-0241-2007 · Terumo Cardiovascular Systems Corp · posted Dec 7, 2006 · Terminated
The hand crank handle may separate and detach from the unit during use.
- Z-0242-2007 · Terumo Cardiovascular Systems Corp · posted Dec 7, 2006 · Terminated
The hand crank handle may separate and detach from the unit during use.
- Z-0260-2007 · Smiths Medical ASD, Inc. · posted Dec 7, 2006 · Terminated
Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.
- Z-0228-2007 · Accumetrics Inc · posted Dec 6, 2006 · Terminated
The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.
- Z-0248-2007 · Arjo, Inc. · posted Dec 6, 2006 · Terminated
The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from coming loose.
- Z-0249-2007 · Arjo, Inc. · posted Dec 6, 2006 · Terminated
The sling ropes were manufactured with insufficient rope length past the knot to prevent the knot from coming loose.
- Z-0250-2007 · Smiths Medical ASD, Inc. · posted Dec 6, 2006 · Terminated
IV Fluid Administration Set may have a blockage of the recirculating warming fluid channel within the disposable administration set, causing an alarm condition of over-temperature during priming.
- Z-0251-2007 · Smiths Medical ASD, Inc. · posted Dec 6, 2006 · Terminated
IV Fluid Administration Set may have a blockage of the recirculating warming fluid channel within the disposable administration set, causing an alarm condition of over-temperature during priming.
- Z-0252-2007 · BioHorizons Implant Systems Inc · posted Dec 6, 2006 · Terminated
Dental implants were distributed which lacked the proper instruments for implantation.
- Z-0253-2007 · Becton Dickinson & Company · posted Dec 6, 2006 · Terminated
Reports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification.
- Z-0243-2007 · bioMerieux, Inc. · posted Dec 5, 2006 · Terminated
Recovery Compromised-during manufacturing ambient air (including oxygen) was inadvertently introduced into the culture bottles, changing their reduction/oxidation potential thus leading to a compromised recovery of some obligate anaerobes and longer…
- Z-0244-2007 · Teleflex Medical · posted Dec 5, 2006 · Terminated
Mislabeling-The rebreathing bag is incorrectly labeled as a 1 liter bag when it is actually a 1/2 liter bag.
- Z-0245-2007 · Ortho-Clinical Diagnostics · posted Dec 5, 2006 · Terminated
The firm identified circumstances in which biased results or calibration failures can be observed when using any lot of VITROS LIPA slides if they have been stored on the VITROS Chemistry Systems for more than 2 days.
- Z-0246-2007 · Abbott Laboratories · posted Dec 5, 2006 · Terminated
Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results.
- Z-0247-2007 · Dade Behring, Inc. · posted Dec 5, 2006 · Terminated
Product does not meet performance specifications through its standardized inocula for MicroScan Dried Gram-Negative and Gram-Positive Overnight panel testing.
- Z-0229-2007 · Laborie Medical Technologies · posted Dec 1, 2006 · Terminated
Mislabeling: Product labeled with incorrect "Use Before" date and pouch labels missing lot number. (Incorrect dates-2006/07 or 2006/08; correct Use by dates-2009/08 for Lot 36H03M005 and 2009/07 for Lot 36G20M041
- Z-0230-2007 · Dentsply Friadent Ceramed · posted Dec 1, 2006 · Terminated
Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.
- Z-0231-2007 · Dentsply Friadent Ceramed · posted Dec 1, 2006 · Terminated
Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.
- Z-0232-2007 · Dentsply Friadent Ceramed · posted Dec 1, 2006 · Terminated
Sterility of dental implants may be compromised due to cracks in packaging/caps on vials.
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.