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 1441–1460 of 38,428 recalls
Recalled Item: ACCOLADE DR SL (Model L301)
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCOLADE DR EL (Model L321)
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number S701 ALTRUA 2 SR SL Pacemaker
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number L111
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number S722
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCOLADE SR SL (Model L300)
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model Number U125
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCOLADE SR SL MRI (Model L310)
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROPONENT DR SL (Model L201)
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCOLADE DR SL MRI (Model L311)
The Issue: Software to enhance Safety Architecture is available and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Automated Impella Controller (AIC) with the below brands and product
The Issue: Specific Automated Impella Controllers (AICs) that have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vacuette Product Name: 8 ml CAT Serum Separator
The Issue: Some of the Vacuette¿ CAT Serum Separator Clot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CorNeat EverPatch
The Issue: Reviewed complaints have identified that conjunctival wound dehiscence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EverPatch+
The Issue: Reviewed complaints have identified that conjunctival wound dehiscence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICEfx Cryoablation System
The Issue: Certain desiccant tube subassemblies were built with end
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Preventive Maintenance (PM) Kit ICEFX
The Issue: Certain desiccant tube subassemblies were built with end
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
The Issue: Three failure modes have been identified: failure of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017
The Issue: for activation of an abnormal alarm pause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.