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 26841–26860 of 38,428 recalls
Recalled Item: Optical Surface Monitoring System{Align RT Plus} This is used on
The Issue: Varian Medical Systems has received reports that unintended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arial Wireless Water-Resistant Call Pendant The Arial Pendant tag is
The Issue: Devices were incorrectly programmed during manufacturing therefore depressing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products HBsAg Controls
The Issue: The signal/cutoff (s/c) results may increase throughout the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signify Mono (Whole Blood
The Issue: The Positive Control information referencing human plasma as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stratus¿ CS STAT Fluorometric Analyzer-microprocessor-controlled instrument...
The Issue: Software defect, where either an Above Assay Range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: Analytical...
The Issue: Trigger lock option does not always prevent x-ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acceava Mono II Rapid Test Strip (Whole Blood
The Issue: The Positive Control information referencing human plasma as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Babytherm 8004/8010
The Issue: Risk associated with operating the device in skin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AnastoClip AC 8cm 35 Clips (1 Each} Large REF #
The Issue: US marketing brochure for the AnastoClip AC Closure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Henry Schein One Step + Mono Rapid Test Device
The Issue: The Positive Control information referencing human plasma as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Mono Rapid Test
The Issue: The Positive Control information referencing human plasma as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip
The Issue: US marketing brochure for the AnastoClip AC Closure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anastoclip AC 8cm 35 Clips (1 Each} Medium REF #
The Issue: US marketing brochure for the AnastoClip AC Closure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 The Anastoclip
The Issue: US marketing brochure for the AnastoClip AC Closure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proadvantage Mono Rapid Test Cassette
The Issue: The Positive Control information referencing human plasma as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stanbio Rely Mono Rapid Test
The Issue: The Positive Control information referencing human plasma as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anasto AC Closure System and Anasto Universal Clip Remover- Anasto
The Issue: US marketing brochure for the AnastoClip AC Closure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clearview MONO (Whole Blood
The Issue: The Positive Control information referencing human plasma as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 The Anastoclip Clip
The Issue: US marketing brochure for the AnastoClip AC Closure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AnastoCiip Universal Clip Remover (1Each} REF# 4001-04 The Anastoclip Clip
The Issue: US marketing brochure for the AnastoClip AC Closure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.