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 38081–38100 of 38,428 recalls
Recalled Item: SharePlan 1.1
The Issue: This notice concerns behavior of the SharePlan that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Navitrack System - OS Knee Universal
The Issue: Zimmer CAS voluntarily conducted a retrospective recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has become aware of a software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has become aware of potential issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-4873 Custom CT Biopsy Tray
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-8162-R1 Fox Chase Specials Pack containing 2 oz. bottle PVP
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-4975 HSG Tray containing 4 oz. bottle PVP Prep Solution
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington...
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-5284 Custom Myelogram Tray containing 2 oz. bottle PVP Prep
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
The Issue: The firm saw on the FDA web site
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.