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 4161–4180 of 38,428 recalls
Recalled Item: ERIC Retrieval Device ER174030 ER176044 The ERIC Retrieval
The Issue: Due to Retrieval Device product labels stating the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImpellaCP SmartAssistSetAPAC
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella CP Pump 371 Set
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella 5.5 SmartAssist Set
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pump 381 Pump Set (US)
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella 5.5 with SmartAssist Set
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella CP Smart Assist Set APAC
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella CP Smart Assist Set
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella 5.5 SmartAssist S2 Set
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella 5.5 with SmartAssist S2 Set
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella CP Smart Assist Set
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella CP Smart Assist Set
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella 5.5 with SmartAssist S2 Set
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella 5.5 with SmartAssist Set
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella CP Smart Assist Set
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella CP Pump Set
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pump 371 14F LT CMR Set
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella 5.5 Set AU
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella 5.5 with SmartAssist Set
The Issue: A potential device interaction between the Shockwave Coronary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Made Device - GMRS EXTENSION Piece 40MM LEFT
The Issue: A patient specific, custom-made device was supplied for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.