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 32461–32480 of 38,428 recalls
Recalled Item: AXIOM Luminos dRF system with SW VD10 or on Luminos
The Issue: It was determined that a potential malfunction may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35)
The Issue: The device may have a non-conforming component that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous
The Issue: Product not approved for use in the US
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENVOY 500 AST Reagent Kit
The Issue: Some users of ENVOY 500 AST Reagent Kit,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX PENTRA Magnesium RTU Reagent
The Issue: Horiba Medical is recalling the ABX PENTRA Magnesium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prime Care ¿ Transcend Mattress
The Issue: The firm found that the top cover of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group
The Issue: During label reconciliation a duplicate serial number label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels...
The Issue: Technical Support Bulletin issued in February 2013 did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels...
The Issue: Technical Support Bulletin issued in February 2013 did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels...
The Issue: Technical Support Bulletin issued in February 2013 did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels...
The Issue: Technical Support Bulletin issued in February 2013 did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels...
The Issue: Technical Support Bulletin issued in February 2013 did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels...
The Issue: Technical Support Bulletin issued in February 2013 did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels...
The Issue: Technical Support Bulletin issued in February 2013 did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Posiflush Saline Flush Syringe 10 ml inlcuded in the
The Issue: Some unit packages of BD PosiFlush SF Saline
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Posiflush Saline Flush Syringe 10 ml inlcuded in the
The Issue: Some unit packages of BD PosiFlush SF Saline
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Posiflush Saline Flush Syringe 10 ml inlcuded in the
The Issue: Some unit packages of BD PosiFlush SF Saline
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Posiflush Saline Flush Syringe 10 ml inlcuded in the
The Issue: Some unit packages of BD PosiFlush SF Saline
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Posiflush Saline Flush Syringe 10 ml inlcuded in the
The Issue: Some unit packages of BD PosiFlush SF Saline
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument
The Issue: Has a Potential Pinch Hazard to user performing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.