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 16381–16400 of 38,428 recalls
Recalled Item: Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST
The Issue: Components 2mm shorter than indicated on the package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
The Issue: Components 2mm shorter than indicated on the package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
The Issue: Components 2mm shorter than indicated on the package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLASSIC Radiofrequency Cannula - Curved
The Issue: A manufacturing error caused a single lot of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew PROFIX Mallet
The Issue: There is a a potential failure mode associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioJet Ultra Consoles-Thrombectomy System UPN: 105650-001D 105650-001H...
The Issue: Missing Directions for Use (DFU) - Consoles shipped
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CrossCath Support Catheter
The Issue: A manufacturing error may cause the radiopaque marker
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CrossCath Support Catheter
The Issue: A manufacturing error may cause the radiopaque marker
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CrossCath Support Catheter
The Issue: A manufacturing error may cause the radiopaque marker
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CrossCath Support Catheter
The Issue: A manufacturing error may cause the radiopaque marker
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iChem VELOCITY Urine Chemistry Analyzer
The Issue: Beckman Coulter has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for
The Issue: May have a missing locking wire causing delay
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ligamax 5 mm Endoscopic Multiple Clip Applier
The Issue: A potential exists that certain LIGAMAX devices within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cognision
The Issue: Product has the potential to be contaminated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT HAVAB-G Calibrator
The Issue: Abbott has identified that Calibrator lot 08219BE00 is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The FastPack System Comlete Immunoassay Kit Immunoassay for the Quantitative
The Issue: The chemiluminescent immunoassay has been noted to have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rheumatoid Factor (RF) Kit for use on SPAPLUS
The Issue: It has been identified that the rheumatoid factor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle Silicone Filled Breast Implants for the following Styles and
The Issue: The firm has became aware that 2D barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle Saline-Filled Breast Implant
The Issue: The firm has became aware that 2D barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle Inspira Sillicone-Filled Breast Implants for the following Styles and
The Issue: The firm has became aware that 2D barcodes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.