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 35941–35960 of 38,428 recalls
Recalled Item: Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioMend¿ Extend" Absorbable Collagen Membrane BioMend¿ Extend" Absorbable...
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Helitene Absorbable Collagen Hemostatic Sponge Helitene is indicated in surgical
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuraGen Nerve Guide NeuraGen Nerve Guide is indicated for repair
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Absorbable Collagen Sponge Provided As Intermediate to Another Company
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dural Graft Matrix DuraGen¿ Dural Graft Matrix is an absorbable
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural...
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INSTAT - Agent
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Helistat Absorbable Hemostatic
The Issue: Due to the process deviation, product lots in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.