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 37961–37980 of 38,428 recalls
Recalled Item: Toshiba Ultra-Short Magnetic Resonance Imaging System
The Issue: The firm recalled due to a potentail problem
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Columbus Tibia Plateau (component of the Columbus REVISION Knee System)
The Issue: During an internal quality inspection, the tibia plateau
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FLOW-I Anesthesia System The system is intended for use in
The Issue: A technical alarm may be generated on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER
The Issue: The EnFlow Warmer Strap does not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Carescape Patient Data Module with v2.0 software used
The Issue: GE Healthcare became aware of two issues with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle
The Issue: A Discrepancy was found on Hitachi AST (HA7
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical
The Issue: Smiths Medical has identified a software anomaly in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Symbionic Leg is an integrated prosthetic leg for transfemoral
The Issue: OSSUR initiated this recall of the Symbionic Leg
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Empi STIMC RE Self Adhesive electrodes. For use on TENS
The Issue: Covidien is conducting a voluntary recall regarding specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable
The Issue: Covidien is conducting a voluntary recall regarding specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes
The Issue: Covidien is conducting a voluntary recall regarding specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reusable
The Issue: Covidien is conducting a voluntary recall regarding specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra¿ Advansys Medial Lisfranc Plate (MLP)
The Issue: Incorrect technique applied may cause potential rupture of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The finger cots are made out of natural rubber. They
The Issue: The firm is initiating a field correction because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CaviCide
The Issue: Metrex Research is recalling Cavicide containing the Spring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VerifyNow P2Y12 Assay
The Issue: The recall was initiated by Accumetrics because of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VerifyNow System
The Issue: The recall was initiated by Accumetrics because of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: *** 1) Plum A+ Infusion Pump
The Issue: Hospira has received reports of distal pressure sensor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+ Infusion Pump
The Issue: Hospira has received reports of distal pressure sensor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+ Infusion Pump
The Issue: Hospira has received reports of distal pressure sensor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.