Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 35421–35440 of 38,428 recalls
Recalled Item: Getinge Assure Accufast BI Test Pack w/ 25 Controls
The Issue: Mesa Labs, based out of Bozeman, MT, informed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal BI Stat Biological Test Pack with Instant Readout Integrator
The Issue: Mesa Labs, based out of Bozeman, MT, informed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZTest Steam Biological Indicator
The Issue: Mesa Labs, based out of Bozeman, MT, informed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Med-Checks BI Test packs with Instant Readout Integrator
The Issue: Mesa Labs, based out of Bozeman, MT, informed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The
The Issue: Siemens initiate this recall due to a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge Assure Accufast BI Test Pack w/ 5 Controls
The Issue: Mesa Labs, based out of Bozeman, MT, informed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years
The Issue: STAAR Surgical Company is recalling a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Afinity CQ2015A Intraocular Lens The visual correction of aphakia in
The Issue: STAAR Surgical Company is recalling a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StatLock CV Plus w/Pigtail
The Issue: BARD Access Systems is recalling lot JUWJF283 of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Instrument Control Box
The Issue: Factory testing on da Vinci Si Surgical Systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Si Vision System Cart
The Issue: Factory testing on da Vinci Si Surgical Systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Dual Camera Controller
The Issue: Factory testing on da Vinci Si Surgical Systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Si Surgeon Side Cart
The Issue: Factory testing on da Vinci Si Surgical Systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27
The Issue: Error in the printing of the therapy energy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00597002009 Articular Surface CR ART SURF 12/PURPLE 9
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM
The Issue: Surgeons are implanting components of the NexGen Cruciate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.