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 37661–37680 of 38,428 recalls
Recalled Item: Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative
The Issue: Certain lots of the affected products may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triage D-dimer PN 98100 Used as an aid in the
The Issue: Certain lots of the affected products may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere Triage Profiler SOB Panel PN 97300 Used for the
The Issue: Certain lots of the affected products may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere Triage Cardiac Panel PN 97000HS Used for the quantitative
The Issue: Certain lots of the affected products may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intellispace Portal software Product Usage: Intellispace Portal is a...
The Issue: In the Multi-Modality Tumor Tracking application, when changing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere Triage BNP PN 98000XR Intended to be used as
The Issue: Certain lots of the affected products may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Digital Diagnost Software
The Issue: With Digital Diagnost (DIDI) R 2.0.2 a mirrored
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System Software For use in the in-vitro quantitative
The Issue: software automatically switches the lot when a vancomycin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System Software For use in the in-vitro quantitative
The Issue: software automatically switches the lot when a vancomycin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5
The Issue: software automatically switches the lot when a vancomycin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Formula Shaver Handpiece (with buttons)
The Issue: Stryker Endoscopy determined that there may not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Multi Diagnost Eleva II with swivel cable Product Codes
The Issue: MultiDiagnost Eleva X--Ray system may have damage to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympic Cool-Cap System is intended to provide treatment for neonatal
The Issue: Olympic Cool-Cap Cooling Module's power supply failed during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GoBed+ . Model FL20E Beds are intended for medical purposes
The Issue: An adverse trend of scale and bed exit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Rose Bed Model (FL14E) Beds are intended for medical
The Issue: An adverse trend of scale and bed exit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker MA204 Bed Model (FL25E) Beds are intended for medical
The Issue: An adverse trend of scale and bed exit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Go Bed II+ Model FL28C Beds are intended for medical
The Issue: An adverse trend of scale and bed exit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Go Bed II+ Model FL 28 Ex Beds are intended
The Issue: An adverse trend of scale and bed exit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LUSTER HIP SZ 2 Packaging: The product was packaged within
The Issue: DePuy Orthopaedics, Inc. is issuing a Field Safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LUSTER HIP SZ 1 Packaging: The product was packaged within
The Issue: DePuy Orthopaedics, Inc. is issuing a Field Safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.