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 4401–4420 of 38,428 recalls
Recalled Item: NEUROSIGN Disposable Stimulating Dissector
The Issue: Product has have presence of brown discoloration or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivo 45 LS
The Issue: There is a potential for short term (<7
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Barricaid Annular Closure Impactor
The Issue: At least two units have been found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti- Valve
The Issue: The firm received reports of breakage in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker TMJ Unilateral Implant
The Issue: Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube
The Issue: The firm received reports of breakage in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard Clinical Packaging Solutions
The Issue: Medical convenience kits were distributed with Merit syringes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FreeStyle Libre 3 Sensors
The Issue: Users of the FreeStyle Libre 3 sensors reported
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker iBur 3.0mm Coarse Diamond Round
The Issue: for the product to exhibit temperatures higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker iBur 2.0mm Diamond Round
The Issue: for the product to exhibit temperatures higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker iBur 5.0mm Coarse Diamond Round
The Issue: for the product to exhibit temperatures higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker iBur 3.0mm Diamond Round
The Issue: for the product to exhibit temperatures higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Syringe 60CC
The Issue: Affected syringes lack FDA clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker iBur 3.0mm Precision Match Head
The Issue: for the product to exhibit temperatures higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker iBur 4.0mm Coarse Diamond Round
The Issue: for the product to exhibit temperatures higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker iBur 4.0mm Diamond Round
The Issue: for the product to exhibit temperatures higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker iBur 4.0mm Precision Round
The Issue: for the product to exhibit temperatures higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIOVIT AT-180. Model Number: 0A.110000
The Issue: for high-frequency signal artifacts is recorded during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker iBur 3.0mm Precision Round
The Issue: for the product to exhibit temperatures higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker iBur 3.0mm Diamond Match Head
The Issue: for the product to exhibit temperatures higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.