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 38281–38300 of 38,428 recalls
Recalled Item: The LIFEPAK 15 monitor/defibrillator is intended for use by trained
The Issue: Customer complaint was received relating to a LifePak15
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A mobile
The Issue: Customers may be storing objects on the base
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube
The Issue: A report was received from a Japanese distributor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT:
The Issue: The tips of the drivers are breaking while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT:
The Issue: The tips of the drivers are breaking while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems.
The Issue: These camera systems were manufactured by LMGS and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm)
The Issue: Medacta USA is recalling Versafitcup Impacting Ring because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL80 FLEX CO-OX analyzer
The Issue: The recall was initiated because SenDx Medical Inc
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spiegelberg Brain Pressure Monitoring System Probe 3PN
The Issue: In the vast majority of products specified, a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xoran MiniCAT CT Scanner ID ENT00001
The Issue: Failure of the gantry to rotate. The complaint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Foam electrodes with Silver-Carbon construction: P/N 202-9271
The Issue: Electrode Socket Terminal pulling away from the electrode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Foam Electrodes with Carbon construction: P/N 201-1261
The Issue: Electrode Socket Terminal pulling away from the electrode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cloth electrodes with Silver-Carbon construction: P/N 202-9231
The Issue: Electrode Socket Terminal pulling away from the electrode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cloth electrodes with Carbon construction: P/N 201-1231
The Issue: Electrode Socket Terminal pulling away from the electrode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The
The Issue: The recall was initiated because Carefusion has confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface
The Issue: The recall was initiated because Sunquest Information System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended
The Issue: The recall was initiated because Biosense Webster has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus SurgMaster UES-40 electrosurgical unit ("UES-40") Product Usage:...
The Issue: Olympus initiated a software upgrade and enhancement in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 892.1650 Image-intensified fluoroscopic x-ray system
The Issue: GE OEC is recalling certain 9800 Image Intensified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir
The Issue: Backplate reservoir holders were manufactured with an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.