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 28961–28980 of 38,428 recalls
Recalled Item: Destination Renal Guiding Sheath Intended for the introduction of interventional
The Issue: Based on internal investigation and testing that revealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroCutter Xchange 30 Blue Cartridge
The Issue: Cardica, Inc. has received reports that use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroCutter Xchange 30 Blue Curved Tip Cartridge. Model Number: FG-025321
The Issue: Cardica, Inc. has received reports that use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unolok Blunt Fill Needle 18G x 1.5" Red
The Issue: Particulates: Complaints of rubber coring from the closure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10)
The Issue: Antibiotic concentration may be insufficient which may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genesys spine
The Issue: Unanticipated technique for a cervical screw insertion caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RT Elements are applications for radiation treatment planning for use
The Issue: Large objects with fine resolution are potentially displayed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RT Elements are applications for radiation treatment planning for use
The Issue: Large objects with fine resolution are potentially displayed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump SmartSite Infusion Set
The Issue: CareFusion is recalling the Alaris Pump Module SmartSite
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Altrus Thermal Tissue Fusion Energy Sources
The Issue: Miscalibration of the Energy Source monitoring function, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thin-Flex Venous Cannula
The Issue: Edwards Lifesciences initiated a field action for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Copper NiTi Preformed Archwires
The Issue: Ormco Corporation is recalling Copper NiTi Preformed Archwires
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroVue SC5b-9 Plus EIA (CE-IVD)
The Issue: A component of the kit was found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroVue SC5b-9 Plus EIA (RUO)
The Issue: A component of the kit was found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroVue CIC-C1q EIA
The Issue: A component of the kit was found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAMIC CONVENIENCE KIT SELF REGIONAL HEALTHCARE PV LEG PACK
The Issue: Procedure Products initiated the recall due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAMIC CONVENIENCE KIT MERCY GENERAL HOSPITAL NEURO KIT
The Issue: Procedure Products initiated the recall due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAMIC CONVENIENCE KIT HOLYOKE HOSPITAL SPECIAL PROCEDURE KIT
The Issue: Procedure Products initiated the recall due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAMIC CONVENIENCE KIT RENOWN REGIONAL MEDICAL CENTER
The Issue: Procedure Products initiated the recall due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine
The Issue: Siemens Healthcare Diagnostics has confirmed an increase in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.