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 32501–32520 of 38,428 recalls
Recalled Item: Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE
The Issue: AngioDynamics became aware that Uni*Fuse Infusion Systems with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves
The Issue: Catheter Connections is recalling DualCap IV Pole Strips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor
The Issue: The firm became aware of a potential problem
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAP Change Kit w/MicroClave Clear
The Issue: ICU Medical is recalling the BD PosiFlush Sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cap Change Kit with MicroClave Clear Connector
The Issue: ICU Medical is recalling the BD PosiFlush Sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Port Access Kit with MicroClave Clear Connector
The Issue: ICU Medical is recalling the BD PosiFlush Sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Split Cath III Trays
The Issue: The Split Cath III Trays were incorrectly labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vac-Assist Suction Units (SUA01 Suction Aspirator Unit w/800 cc Canister).
The Issue: suction canister lids may have occluded ports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ST¿CKERT HeaterCooler System 3T
The Issue: On August 1, 2014 Sorin Group USA, Inc
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CollectEVAC
The Issue: A pinhole leak identified in the packaging of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pinnacle3 Software Version 9.0
The Issue: Philips, Pinnacle Radiation Treatment Planning System version 8.0h,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The
The Issue: It was discovered that a software defect may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mindray V21
The Issue: Mindray DS USA Inc. initiated a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion AirLife Heated Infant Breathing Circuit Product Usage:...
The Issue: The CareFusion AirLife Heated Infant Breathing Circuit is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche cobas IT 1000 Product Usage: Intended Use: An electronic
The Issue: that test results would be assigned to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLAW II 2 HOLE PLATE ORTHOLOC 3DSi
The Issue: Plates manufactured from an incorrect raw material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM
The Issue: Plates manufactured from an incorrect raw material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLAW II 2 HOLE PLATE ORTHOLOC 3DSi
The Issue: Plates manufactured from an incorrect raw material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLAW II 2 HOLE PLATE ORTHOLOC 3DSi
The Issue: Plates manufactured from an incorrect raw material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLAW II STRAIGHT PLATE ORTHOLOC 3DSi
The Issue: Plates manufactured from an incorrect raw material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.