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 2361–2380 of 38,428 recalls
Recalled Item: Halyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
The Issue: An issue with a raw material used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
The Issue: An issue with a raw material used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
The Issue: An issue with a raw material used to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The
The Issue: crack in the female connector located on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile
The Issue: crack in the female connector located on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin
The Issue: Siemens Healthcare Diagnostics Inc., is recalling their Stratus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Straight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile
The Issue: crack in the female connector located on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Straight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile
The Issue: crack in the female connector located on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rover Product Name: Mobile X-ray System Model/Catalog Number:
The Issue: for early life x-ray tube failure for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rover Product Name: Mobile X-ray System Model/Catalog Number:
The Issue: for early life x-ray tube failure for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guide Wire with Ruler Tube 3x800 mm DIA
The Issue: The metal ring at the end of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guide Wire with Ruler Tube 3x1000 mm DIA
The Issue: The metal ring at the end of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GALT Guidewire Guidewires are intended for use in
The Issue: Due to a potential open seal in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B Braun Interventional Coaxial Dilator
The Issue: Due to a potential open seal in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF
The Issue: Due to a potential open seal in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intraocular Lens. enVista Envy IOL
The Issue: In response to an increased number of reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Introducer Kit- Tearaway MicroSlide
The Issue: Due to a potential open seal in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Introducer Needle These needles are used for the
The Issue: Due to a potential open seal in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Introducer Kit- Coaxial Dilator
The Issue: Due to a potential open seal in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intraocular lens. enVista Monofocal IOL
The Issue: In response to an increased number of reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.