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 29281–29300 of 38,428 recalls
Recalled Item: Inserter for Titanium Elastic Nails (TEN)
The Issue: for mechanical failures such as breakage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer
The Issue: In about 5% of tested samples, the outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop
The Issue: Kit Label incorrect :Labeled with Lidocaine HCI drug
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPAX
The Issue: Customers have experienced IMPAX CV software, specifically, Demographics
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic CryoConsole
The Issue: An issue with a USB memory component contained
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Sterile Custom Sterile Custom Surgical Kits containing 3M DuraPrep
The Issue: Custom Sterile Surgical kits contain 3M DuraPrep (TM)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fujifilm Medical Systems Duodenoscope
The Issue: A precautionary measure because the Duodenoscopes have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: When performing head or neck scans, the currently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: When performing head or neck scans, the currently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: When performing head or neck scans, the currently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: When performing head or neck scans, the currently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: When performing head or neck scans, the currently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical
The Issue: Custom Sterile Surgical kits contain 3M DuraPrep (TM)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: When performing head or neck scans, the currently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: When performing head or neck scans, the currently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MATResponder Tourniquet
The Issue: Once tested, it is required that the tourniquet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2
The Issue: May contain small amounts of ethylene glycol residue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConFormis iTotal CR Knee Replacement System- iTOTAL CR
The Issue: May contain small amounts of ethylene glycol residue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConForMIS iUni Unicondylar Knee Replacement System- iUNI G2
The Issue: May contain small amounts of ethylene glycol residue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2
The Issue: May contain small amounts of ethylene glycol residue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.