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 11681–11700 of 38,428 recalls
Recalled Item: REF/Catalogue Number GSXE0025B
The Issue: Septal Occluders contain the incorrect expiration date. Product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REF/Catalogue Number GSXE0030B
The Issue: Septal Occluders contain the incorrect expiration date. Product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REF/Catalogue Number GSXE0020
The Issue: Septal Occluders contain the incorrect expiration date. Product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REF/Catalogue Number GSX0030A
The Issue: Septal Occluders contain the incorrect expiration date. Product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REF/Catalogue Number GSXE0025
The Issue: Septal Occluders contain the incorrect expiration date. Product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m
The Issue: There is a potential for false positive results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology
The Issue: Engraving on implants may not match what is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology
The Issue: Engraving on implants may not match what is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MYLA Versions: 4.7
The Issue: Under certain conditions, there is a risk for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m
The Issue: There is a potential for false positive results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization
The Issue: There is a potential for false positive results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m
The Issue: There is a potential for false positive results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization
The Issue: There is a potential for false positive results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ Oncology Information System
The Issue: A drug strength in MOSAIQ can be changed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation...
The Issue: DeRoyal manufactured procedure packs containing a Smiths Medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flower Drill Bit Kit 2.0 mm - intended to be
The Issue: Drill bits packaged in kits are missing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flower Lag Screw Kit 2.7 mm-intended to be used with
The Issue: Drill bits packaged in kits are missing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flower Drill Bit Kit 2.4 mm-intended to be used with
The Issue: Drill bits packaged in kits are missing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flower Drill Bit Kit 2.7mm- The Drill Bit Kit
The Issue: Drill bits packaged in kits are missing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Sterile single-use blades that are components of the StraightShot
The Issue: There was an increase in complaints related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.