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 27801–27820 of 38,428 recalls
Recalled Item: NecLoc Extrication Collar Product Usage: Necloc collars are applied to
The Issue: Ossur Americas is recalling , Knee Shield /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unloader Custom Product Usage: Unloader Custom is an external knee
The Issue: Ossur Americas is recalling , Knee Shield /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used
The Issue: Ossur Americas is recalling , Knee Shield /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup
The Issue: Ossur Americas is recalling , Knee Shield /
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo X Workplace is a medical workstation for real-time viewing
The Issue: After importing, the segmentation results appear mirrored at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RESTORIS PST RIO Offset Shell Impactor For use by orthopedic
The Issue: disassociation of the orientation pin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649...
The Issue: Customers may not receive an intended audible alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver
The Issue: Customers may not receive an intended audible alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
The Issue: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL)
The Issue: Customers may not receive an intended audible alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL)
The Issue: Customers may not receive an intended audible alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUADROX-i oxygenators Custom tubing packs for the oxygenator
The Issue: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number:
The Issue: Customers may not receive an intended audible alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator
The Issue: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X-Guide Surgical Navigation System
The Issue: The X-Guide system utilizes an X-Clip (PN P007665)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Tubing Packs Custom tubing pack for oxygenators
The Issue: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495
The Issue: Customers may not receive an intended audible alarm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titanium Low Profile Neuro Screw
The Issue: Out of specification at the thread. The thread
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titanium Low Profile Neuro Screw
The Issue: Out of specification at the thread. The thread
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reveal LINQ insertable Cardiac Monitor
The Issue: Medtronic has identified an issue with the sensitivity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.