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 2201–2220 of 38,428 recalls
Recalled Item: Catalog No. 8888160341
The Issue: Packaging defect may compromise sterility of the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pre-filled Water Syringe
The Issue: During endoscope surveillance monitoring, a user facility identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog No. 8888160119
The Issue: Packaging defect may compromise sterility of the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog No. 8888160325
The Issue: Packaging defect may compromise sterility of the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog No. 8888160333
The Issue: Packaging defect may compromise sterility of the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog No. 8888160648
The Issue: Packaging defect may compromise sterility of the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catalog No. 8888160556
The Issue: Packaging defect may compromise sterility of the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeShield Drug Library Management (DLM)
The Issue: Firm has identified Drug Library Management defects in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Drill Stop Kit is the version of the Mini
The Issue: The Drill stop kit contains incorrect components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth...
The Issue: Product may have an off color affecting perfomance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adult Manual Resuscitator with Medium Adult Mask
The Issue: Affected lots were manufactured with B/V Filter incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BX2 Needle Guide
The Issue: During the attachment of the needle guide to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GM Helix Acqua Implant
The Issue: It is possible that a package labelled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GM Helix Acqua Implant
The Issue: It is possible that a package labelled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sample probe sucks a sample dispensed into a tube or
The Issue: A manufacturing defect in the sample probe (S
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sample probe sucks a sample dispensed into a tube or
The Issue: Sample probes with defective probe tips, when used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFire Respiratory Panel 2.1 plus Kit
The Issue: Due to manufacturing error, respiratory panel may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to
The Issue: HKH 8820 Wall Holder does not comply with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5008X HDF Hemodialysis Blood Tubing Set
The Issue: of blood leak occurring between the lower
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azure S DR MRI SureScan
The Issue: Identified devices may experience sudden battery power failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.