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 17421–17440 of 38,428 recalls
Recalled Item: AGFA Digital Radiography X- Ray system DR 800 with MUSICA
The Issue: The exposed area of fluo exams possibly does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMRIS MR/X-ray head fixation device
The Issue: Breaking of the HFD200 Drive Knob force indicator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartRelease Endoscopic Carpal Tunnel Release Handpiece (ECTR handpiece)
The Issue: There was a higher than normal incidence rate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGEC 1 System
The Issue: Safety Alert to all surgeons informing them of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Go-EZ Screw 6.5x120
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Wire Single Trocar 2.5x150mm
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Go-EZ Screw 6.5x34
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Go-EZ Screw 6.5x95
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Go-EZ Screw 6.5x38
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Wire Single Trocar 1.6x150mm
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Wire Sterile Single Trochar .045
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Wire HBS Sterile
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Go-EZ Screw 6.5x30
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Go-EZ Screw 6.5x100
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Wire Single Trocar 2.5x170mm
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Go-EZ Screw 6.5x36
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Go-EZ Screw 6.5x32
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Go-EZ Screw 6.5x105
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Wire HBS Sterile Lot
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Wire Sterile Single Trochar
The Issue: Manufacturing flaw in the sterile barrier system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.