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 6461–6480 of 38,428 recalls
Recalled Item: Vascu-Guard Peripheral Vascular Patch (GLOBAL)
The Issue: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Preveleak Surgical Sealant
The Issue: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Ostene Hemostasis Material
The Issue: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Vascular Probe
The Issue: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peri-Guard Repair Patch
The Issue: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter FloSeal Hemostatic Matrix RECOTHROM
The Issue: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peri-Guard Repair Patch
The Issue: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella Connect
The Issue: The following features have been disabled from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound EA (Ergonomic Advantage) table versions
The Issue: Backrest platform stress fracture - the table is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound EA (Ergonomic Advantage) table versions
The Issue: Backrest platform stress fracture - the table is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound EA (Ergonomic Advantage) table version
The Issue: Backrest platform stress fracture - the table is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasound EA (Ergonomic Advantage) table versions
The Issue: Backrest platform stress fracture - the table is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ambu aView 2 A Monitor
The Issue: Instructions for Use have been updated to add
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover" 100% SILICONE 400ML U/M TEMP SENSE FOLEY TRAY
The Issue: Convenience kits were manufactured and distributed with components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover" IRRIGATION 1200 CC TRAY
The Issue: Convenience kits were manufactured and distributed with components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRACH KIT W/HYDROGEN & SALI
The Issue: Convenience kits were manufactured and distributed with components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover" 100% SILICONE 400 ML U/M FOLEY TRAY
The Issue: Convenience kits were manufactured and distributed with components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover" 100% SILICONE 400 ML U/M FOLEY TRAY
The Issue: Convenience kits were manufactured and distributed with components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover" 100% SILICONE FOLEY TRAY
The Issue: Convenience kits were manufactured and distributed with components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY
The Issue: Convenience kits were manufactured and distributed with components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.