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 15721–15740 of 38,428 recalls
Recalled Item: Prismaflex System
The Issue: Baxter is communicating safety information from the Prismaflex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex Pilling Aortic Punch
The Issue: The sterile packaging has the potential to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monitor for the Functional Imaging System for Magnetic Resonance Imaging System
The Issue: Insufficient shielding of Philips SensaVue DVI Adapter for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK 2 card AST-N371 - Product Usage: The VITEK 2
The Issue: The top seal of some of the pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200
The Issue: Due to high discordant Estradiol results which.potentially affects
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and
The Issue: Due to high discordant Estradiol results which.potentially affects
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEMO-7 Hemospray Endoscopic Hemostat
The Issue: Complaints that the handle and/or activation knob on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEMO-10 Hemospray Endoscopic Hemostat
The Issue: Complaints that the handle and/or activation knob on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as
The Issue: Cardinal Health gowns contain an unknown level of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VNS Therapy Programmer
The Issue: False positive warning may occur after: 1) VNS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as
The Issue: Cardinal Health gowns contain an unknown level of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion Alaris System
The Issue: 1)Error 255-XX-XXX results in inability to edit settings
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion Alaris PCA Module
The Issue: 1)Error 255-XX-XXX results in inability to edit settings
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion Alaris Pump Module
The Issue: 1)Error 255-XX-XXX results in inability to edit settings
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion Alaris Syringe Module
The Issue: 1)Error 255-XX-XXX results in inability to edit settings
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as
The Issue: Cardinal Health gowns contain an unknown level of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as
The Issue: Cardinal Health gowns contain an unknown level of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as
The Issue: Cardinal Health gowns contain an unknown level of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as
The Issue: Cardinal Health gowns contain an unknown level of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as
The Issue: Cardinal Health gowns contain an unknown level of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.