Medical device recalls: October 2006
The FDA posted 107 medical device recall records in October 2006, from 57 recall events by 51 companies. 107 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
- GE OEC Medical Systems, Inc · 3 events, 3 records
- Siemens Medical Solutions USA, Inc · 2 events, 4 records
- AGFA Corp. · 2 events, 2 records
- Ge Healthcare · 2 events, 2 records
- Thoratec Corp · 2 events, 2 records
- Conmed Corporation · 1 event, 32 records
- Cardinal Health · 1 event, 5 records
- Smiths Medical MD, Inc. · 1 event, 4 records
FDA root cause
- Other · 72
- Nonconforming Material/Component · 32
- Software design · 1
- Process design · 1
- Process control · 1
Not yet classified (107)
The FDA has posted these records but has not published a class for them yet.
- Z-0079-2007 · ATS Medical, Inc. · posted Oct 28, 2006 · Terminated
Incorrect Expiration Date: Three lots of the FrostByte (TM) clamp packaged with SurgiFrost 7 cm cryosurgical probes have incorrect expiration dates. These lots are labeled with a two (2) year expiratation date while the correct date is one (1) year.
- Z-0080-2007 · Cook, Inc. · posted Oct 28, 2006 · Terminated
The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40)
- Z-0081-2007 · Boston Scientific Corp · posted Oct 28, 2006 · Terminated
Sterility compromised/package integrity : the bottom of the Tyvek pouch may not have been sealed.
- Z-0082-2007 · Tosoh Bioscience Inc · posted Oct 28, 2006 · Terminated
Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate the instrument
- Z-0115-2007 · Radiometer America Inc · posted Oct 28, 2006 · Terminated
Incorrect FI02 values: programming issue can cause incorrect values to be transmitted to the LIS when : 1)- The FIO2 result is edited in the manual sample processing mode--2)- An existing result is opened and FI02 is then edited and sent.....In both cases…
- Z-0116-2007 · Venoscope LLC · posted Oct 28, 2006 · Terminated
Excessive heating due to incorrect wire assembly process.
- Z-0077-2007 · Ortho-Clinical Diagnostics · posted Oct 27, 2006 · Terminated
Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre)
- Z-0078-2007 · Hardy Media Inc Dba Hardy Diag · posted Oct 27, 2006 · Terminated
Performance failure; the product is failing to show pigment development for E. coli 0157.
- Z-0083-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0084-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0085-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0086-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0087-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0088-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0089-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0090-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0091-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0092-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0093-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0094-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0095-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0096-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0097-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0098-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0099-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0100-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0101-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0102-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0103-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The company was made aware of instances where the grasper jaws broke during laparoscopic procedures. When the grasper jaws had broken they had done so at the junction of the jaw and the tube. In no instances was it reported to the company that small…
- Z-0104-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0105-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0106-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0107-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0108-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0109-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0110-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0111-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0112-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0113-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0114-2007 · Conmed Corporation · posted Oct 27, 2006 · Terminated
The grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.
- Z-0041-2007 · GE OEC Medical Systems, Inc · posted Oct 25, 2006 · Terminated
Missing, mixed or lost patient images may result after X-ray procedures. Error in navigation accuracy.
- Z-0069-2007 · Siemens Medical Solutions USA, Inc · posted Oct 25, 2006 · Terminated
Potential loss of images. Images may not successfully be sent to the RAID system.
- Z-0070-2007 · Siemens Medical Solutions USA, Inc · posted Oct 25, 2006 · Terminated
Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.
- Z-0071-2007 · Siemens Medical Solutions USA, Inc · posted Oct 25, 2006 · Terminated
Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.
- Z-0072-2007 · Siemens Medical Solutions USA, Inc · posted Oct 25, 2006 · Terminated
Potential issue with annotation function. Annotations, shown as overlays, may change font size when the image is saved. Text may appear shifted, or lines appear thicker, and their position may not be as intended.
- Z-0073-2007 · Sebia, Inc. · posted Oct 25, 2006 · Terminated
The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.
- Z-0063-2007 · Invacare Corporation · posted Oct 24, 2006 · Terminated
The incorrect caution label that describes washing instructions was applied to beds distributed in the US, i.e. the specified label is P/N 1116654 (English translation); the label that was used is P/N 1119165 (French translation).
- Z-0064-2007 · Smiths Medical MD, Inc. · posted Oct 24, 2006 · Terminated
Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are…
- Z-0065-2007 · Smiths Medical MD, Inc. · posted Oct 24, 2006 · Terminated
Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are…
- Z-0066-2007 · Smiths Medical MD, Inc. · posted Oct 24, 2006 · Terminated
Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are…
- Z-0067-2007 · Smiths Medical MD, Inc. · posted Oct 24, 2006 · Terminated
Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are…
- Z-0068-2007 · Organogenesis, Inc. · posted Oct 24, 2006 · Terminated
Product pH out of specification
- Z-0051-2007 · Kendall a Division of Tyco Healthcare Group LP · posted Oct 21, 2006 · Terminated
Incorrect needle: There is an incorrect needle configuration on the syringe. The correct needle has a 27 gage A-bevel, the needle on the syringe has no bevel, typically used for dental irrigation.
- Z-0054-2007 · Ge Healthcare · posted Oct 21, 2006 · Terminated
System Warning Alarm failure: When a patient being monitored is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing yellow border around the…
- Z-0057-2007 · Depuy Orthopaedics, Inc. · posted Oct 21, 2006 · Terminated
Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.
- Z-0058-2007 · Cardinal Health · posted Oct 21, 2006 · Terminated
The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.
- Z-0059-2007 · Cardinal Health · posted Oct 21, 2006 · Terminated
The cardiovascular drape may tear and fray at the reinforced fenestrated trough area during use.
- Z-0060-2007 · Cardinal Health · posted Oct 21, 2006 · Terminated
The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.
- Z-0061-2007 · Cardinal Health · posted Oct 21, 2006 · Terminated
The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.
- Z-0062-2007 · Cardinal Health · posted Oct 21, 2006 · Terminated
The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.
- Z-0022-2007 · Medtronic Neuromodulation · posted Oct 20, 2006 · Terminated
The Catheter Access Port (CAP) on SynchroMed EL pumps manufactured between March and July 1999 may detach from the main body of the pump, which can interrupt drug flow to the target site.
- Z-0052-2007 · AGA Medical Corporation · posted Oct 20, 2006 · Terminated
AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices. Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. This…
- Z-0053-2007 · AGA Medical Corporation · posted Oct 20, 2006 · Terminated
AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices. Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. The…
- Z-0055-2007 · Ge Healthcare · posted Oct 20, 2006 · Terminated
When a patient being monitored with ApexPro/Apex Pro CH Telemetry with ST monitoring disabled is in a pre-existing condition of continuous MESSAGE or ADVISORY level alarm preceding a SYSTEM WARNING level alarm, the SYSTEM WARNING audible alarm and flashing…
- Z-0056-2007 · EM Innovations Inc · posted Oct 20, 2006 · Terminated
The firm failed to include User Instructions with the Stic Kit Needle Containment Device, Model EMI 82691, which they shipped to distributor/customers.
- Z-0039-2007 · Eagle Parts and Products · posted Oct 19, 2006 · Terminated
The wheel hub bolts may loosen resulting in the wheels coming off.
- Z-0040-2007 · Eagle Parts and Products · posted Oct 19, 2006 · Terminated
The wheel hub bolts may loosen resulting in the wheels coming off.
- Z-0043-2007 · Bioplate Inc · posted Oct 19, 2006 · Terminated
Lack of device sterilization: An internal investigation found products were released for distribution labeled as sterile, but the lot was not sterilized.
- Z-0044-2007 · Excelsior Medical Corp · posted Oct 19, 2006 · Terminated
The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes.
- Z-0045-2007 · Eatonform Inc · posted Oct 19, 2006 · Terminated
Certain lots of packet components of the firm's Doc-U-Dose Prescription Management System are separating from the paper along the sealed seam at the bottom of the packets causing the medications inside the separated compartments to fall completely out of…
- Z-0046-2007 · Smiths Medical ASD, Inc. · posted Oct 19, 2006 · Terminated
The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.
- Z-0047-2007 · Respironics California Inc · posted Oct 19, 2006 · Terminated
This action is being initiated due to power supply snubber board failures on certain Esprit Ventilators in countries that utilize operating voltages of 200-240 Volts AC and will involve the replacement of the Esprit Ventilator power supply snubber board.…
- Z-0048-2007 · Draeger Medical, Inc. · posted Oct 19, 2006 · Terminated
One of four casters may break loose from chassis
- Z-0049-2007 · Del Medical Systems Group · posted Oct 19, 2006 · Terminated
The x-ray tube head assembly of the Phantom Portable X-Ray System may detach from the boom arm assembly. The tube head could fall and contact the patient or operator.
- Z-0050-2007 · Medtronic Sofamor Danek Instrument Manufacturing · posted Oct 19, 2006 · Terminated
Bone reamer may not have a cutting surface on the tip.
- Z-0036-2007 · Medline Industries Inc · posted Oct 17, 2006 · Terminated
Under conditions of heavy use, signs of overheating of the main battery cables have been observed.
- Z-0037-2007 · Medline Industries Inc · posted Oct 17, 2006 · Terminated
Under conditions of heavy use, signs of overheating of the main battery cables have been observed.
- Z-0038-2007 · Sunrise Medical · posted Oct 17, 2006 · Terminated
Potential for oxygen cylinders to not fill completely
- Z-0026-2007 · Extended Care Air Therapy Systems Inc · posted Oct 14, 2006 · Terminated
Component defect- Following assembly and distribution, two (2) bolts may bend in the bed frame, which may allow the bed to tip into the wall
- Z-0042-2007 · GE OEC Medical Systems, Inc · posted Oct 14, 2006 · Terminated
X-ray system may lose or mix images and/or lose patient data.
- Z-0002-2007 · Guidant Corporation · posted Oct 12, 2006 · Terminated
Final software load did not occur prior to shipment of select programmers.
- Z-0023-2007 · Abbott Diagnostic International, Ltd. · posted Oct 12, 2006 · Terminated
Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.
- Z-0024-2007 · Abbott Diagnostic International, Ltd. · posted Oct 12, 2006 · Terminated
Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.
- Z-0025-2007 · Abbott Diagnostic International, Ltd. · posted Oct 12, 2006 · Terminated
Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient results have shifted upwards over time together.
- Z-0028-2007 · Lumenis Inc. · posted Oct 12, 2006 · Terminated
Device lacks the black indicator markings on the metal tip and there is the potential for fiber degradation (detachment of the metal cap, and the fiber lasing straight) during use.
- Z-0029-2007 · Hitachi Medical Systems America Inc · posted Oct 12, 2006 · Terminated
Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not change between the images as they rotate.
- Z-0030-2007 · Arrow International Inc · posted Oct 12, 2006 · Terminated
The print identifying the two extension lines, CVP Proximal and PA Distal, are reversed.
- Z-0031-2007 · AGFA Corp. · posted Oct 12, 2006 · Terminated
Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss.
- Z-0032-2007 · Gambro Renal Products, Inc. · posted Oct 12, 2006 · Terminated
A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.
- Z-0033-2007 · AGFA Corp. · posted Oct 12, 2006 · Terminated
Failed CAD displayed as 'No Findings'
- Z-0034-2007 · Becton Dickinson & Company · posted Oct 12, 2006 · Terminated
A complaint was received regarding a BD blood collection set where the blister was noticeably warped. The seal width was below minimum specification. Some blisters could adhere together and crack upon separation. Some units may have pre-activated or have…
- Z-0035-2007 · Haemonetics Corporation · posted Oct 12, 2006 · Terminated
Faulty circuit board may short circuit and cause electric shock to operator
- Z-0027-2007 · 3M Company / Medical Division · posted Oct 11, 2006 · Terminated
3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing.
- Z-0016-2007 · Sunrise Medical CCG, Inc. · posted Oct 5, 2006 · Terminated
The control box used in the actuator systems appears to have a potential to become stuck in one position resulting a non-functioning bed.
- Z-0017-2007 · Hill-Rom, Inc. · posted Oct 5, 2006 · Terminated
The patient pendant cord represents a potential trip hazard for the patient or the caregiver.
- Z-0012-2007 · Integrated Orbital Implants Inc · posted Oct 4, 2006 · Terminated
The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box applied by the contract packager is correct in identifying the product as ''20 mm''.
- Z-0015-2007 · Thoratec Corp · posted Oct 4, 2006 · Terminated
During use an unexpected flaking of the inner surface coating (blood contact) that has the potential for risk of embolism.
- Z-0001-2007 · GE OEC Medical Systems, Inc · posted Oct 3, 2006 · Terminated
Weld defect- the weld between the post body and the screw was not properly formed and can fail, even when minimal force is used.
- Z-0003-2007 · Axis-Shield Diagnostics, Ltd. · posted Oct 3, 2006 · Terminated
The preservative sodium azide used in the Kit Negative Control (part number FCOM175) was at the wrong concentration - the Kit Negative Control contains 0.2% sodium azide rather than the intended 0.1%.
- Z-0004-2007 · Thoratec Corp · posted Oct 3, 2006 · Terminated
Sticky Valve Disk- The valve disk has an increased tendency to stick during operation causing noise and pressure/vacuum alarms.
- Z-0005-2007 · Stryker Instruments Div. of Stryker Corporation · posted Oct 3, 2006 · Terminated
A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
- Z-0006-2007 · Stryker Instruments Div. of Stryker Corporation · posted Oct 3, 2006 · Terminated
A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
- Z-0007-2007 · Stryker Instruments Div. of Stryker Corporation · posted Oct 3, 2006 · Terminated
A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
- Z-0008-2007 · Stryker Instruments Div. of Stryker Corporation · posted Oct 3, 2006 · Terminated
A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire.
- Z-0009-2007 · Smith & Nephew Inc · posted Oct 3, 2006 · Terminated
Tibial punches were not manufactured to specification and could break at the tip during use.
- Z-0010-2007 · Smith & Nephew Inc · posted Oct 3, 2006 · Terminated
Tibial punches were not manufactured to specification and could break at the tip during use.
- Z-0011-2007 · Smith & Nephew Inc · posted Oct 3, 2006 · Terminated
Tibial punches were not manufactured to specification and could break at the tip during use.
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.