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 7741–7760 of 38,428 recalls
Recalled Item: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP)
The Issue: IABP may lose the ability to charge batteries
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP)
The Issue: An unexpected shutdown of the IABP may occur
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP)
The Issue: An unexpected shutdown of the IABP may occur
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Design Options¿ / Epidural anesthesia kit (10 count carton)
The Issue: Kits were assembled with the incorrect Filter Straw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Ergo Impactor Handle
The Issue: The ball and spring housed within the locking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERIGENE Clostridium difficile Nucleic Acid Test
The Issue: It is possible that in rare instances the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Verigene Enteric Pathogens Nucleic Acid Test (EP)
The Issue: It is possible that in rare instances the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perifix¿ / Epidural anesthesia kit (10 count carton)
The Issue: Kits were assembled with the incorrect Filter Straw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Shoulder GPS Impactor Handle
The Issue: The ball and spring housed within the locking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Cytosponge Cell Collection Device
The Issue: Cell Collection Device may be at increased risk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter DxA Automation System
The Issue: A software defect in the DxA Automation System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter DxA Automation System
The Issue: A software defect in the DxA Automation System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc BGEM Crea Test Card with epoc Host SW v3.37.3
The Issue: There is potential for discrepant high glucose results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc BGEM Test Card (BUN & TCO2)
The Issue: There is potential for discrepant high glucose results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc BGEM BUN Test Card with epoc Host SW v3.37.3
The Issue: There is potential for discrepant high glucose results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during
The Issue: Firm has received reports of patient burns in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during
The Issue: Firm has received reports of patient burns in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during...
The Issue: Firm has received reports of patient burns in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
The Issue: Firm has received reports of patient burns in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
The Issue: Firm has received reports of patient burns in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.