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 12741–12760 of 38,428 recalls
Recalled Item: Alaris Pump Module
The Issue: Bezel repair parts used, not by the original
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard Dressing Change Tray
The Issue: ChloraPrep applicators in the kit can grow organisms
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The AMS 700 Inflatable Penile Prosthesis is a closed fluid-filled
The Issue: An AMS 700 100 mL Spherical Reservoir with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KIT_INFINITY_BASE Custom Procedural Kit - Italy
The Issue: Tip Guides are potentially misaligned laterally which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS¿ Black Slides CATALOG #: J02316 - Product Usage:
The Issue: Delayed results. Ortho confirmed that two lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InCore Lapidus Disposable Kit 28mm Left
The Issue: Product could potentially contain an undersized inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFINITY_TRAY Custom Procedural Kit - Canada. containing Infinity ACL Tibial
The Issue: Tip Guides are potentially misaligned laterally which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number:...
The Issue: Some Artis zee ceiling systems show an increased
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InCore Lapidus Disposable Kit 28mm Right
The Issue: Product could potentially contain an undersized inner diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVplasty
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVplasty 10G
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL)
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVplasty Direct Access Diamond Tip Trocar
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVPlasty
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVplasty System
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVplasty Unipedicular Cement Delivery Cannula Kit
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVplasty System
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZVplasty Directional Cement Cannula (4 pieces per pack)
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.