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 9201–9220 of 38,428 recalls
Recalled Item: Non-sterile procedural trays labeled as MAJOR/MINOR
The Issue: for sterile blades, within non-sterile SPT kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-sterile procedural trays labeled as ORTHO TRAUMA
The Issue: for sterile blades, within non-sterile SPT kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-sterile procedural trays labeled as CRANI
The Issue: for sterile blades, within non-sterile SPT kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-sterile procedural trays labeled as TOTAL KNEE KIT
The Issue: for sterile blades, within non-sterile SPT kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS
The Issue: for sterile blades, within non-sterile SPT kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-sterile procedural trays labeled as LAPAROTOMY CDS
The Issue: for sterile blades, within non-sterile SPT kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-sterile procedural trays labeled as LAPAROSCOPIC
The Issue: for sterile blades, within non-sterile SPT kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the
The Issue: Lower than expected iPTH patient and Quality Control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Programmable Diagnostic Computer
The Issue: The firm will be performing a software update
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B105P Patient Monitor (with E-module slot option)
The Issue: GE Healthcare has become aware that if certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B125M Patient Monitor
The Issue: GE Healthcare has become aware that if certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B125P Patient Monitor (with E-module slot option)
The Issue: GE Healthcare has become aware that if certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B105M Patient Monitor
The Issue: GE Healthcare has become aware that if certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B125M Patient Monitor
The Issue: GE Healthcare has become aware that if certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1
The Issue: knot tensile strengths were observed to be significantly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConvaTec AQUACEL Foam Ag Adhesive
The Issue: ConvaTec are voluntarily recalling a batch of AQUACEL¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iTotal Identity Impactor Handle
The Issue: Loctite thread locker (epoxy) may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409:
The Issue: The firm has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Alinity m System
The Issue: The instrument was found to be installed without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power-PRO 2
The Issue: Cot may experience unintended motion due to damaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.