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 34281–34300 of 38,428 recalls
Recalled Item: Ziehm Solo C-Arm Interventional Fluoroscopic X-Ray System. Mobile...
The Issue: Engineering change in 2006 resulted in a minor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Vision(2) FD C-Arm Interventional Fluoroscopic X-Ray System. Mobile...
The Issue: Engineering change in 2006 resulted in a minor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Vision C-Arm Interventional Fluoroscopic X-Ray System. Mobile...
The Issue: Engineering change in 2006 resulted in a minor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Vision R C-Arm Interventional Fluoroscopic X-Ray System. Mobile...
The Issue: Engineering change in 2006 resulted in a minor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Vision RFD C-Arm Interventional Fluoroscopic X-Ray System. Mobile...
The Issue: Engineering change in 2006 resulted in a minor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M ESPE Imprint II Regular Body
The Issue: Specific lots of Imprint II and Paradigm impression
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: All brochures printed before November 20
The Issue: Brochures and web site information for the HyperBlue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit
The Issue: Stryker received reports from the field of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 10 configuration)
The Issue: Sterility of device may be compromised due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 5 configuration)
The Issue: Sterility of device may be compromised due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORCHESTRA/ORCHESTRA PLUS Programmer
The Issue: Sorin has voluntarily issued a notification to physicians
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 1 configuration)
The Issue: Sterility of device may be compromised due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 1 configuration)
The Issue: Sterility of device may be compromised due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TWISTER PLUS 22mm Rotatable Retrieval Device (Box of 10 configuration)
The Issue: Sterility of device may be compromised due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TWISTER PLUS 26mm Rotatable Retrieval Device (Box of 5 configuration)
The Issue: Sterility of device may be compromised due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Indus Invue Screws: IM71058-XX: 04.2mm
The Issue: Mismarked and unmarked screws
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PedFuse Reset Screw Inserters
The Issue: Screw inserters may not mate properly with hex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Indus Invue Screws: IM71013-XX: Indus Screw04.0mm SelfDrilling. Used to secure
The Issue: Mismarked and unmarked screws
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.