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 22781–22800 of 38,428 recalls
Recalled Item: Axiom Artis model Interventional fluoroscopic x-ray foot switch accessory
The Issue: The possibility exists for the wireless foot switch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator
The Issue: Philips MRx devices have an EtCO2 module that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula
The Issue: A specific lot of the FlexFlowTM Venous Cannula,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog
The Issue: There have been reported incidents of fluid leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6F Taiga Guiding Catheter
The Issue: Complaints regarding 6F Taiga guide catheter tip detachment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System
The Issue: A faulty footswitch may result in unintended ultrasonic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIRO Mobile CT System
The Issue: If the tilt-drive motor has an intermittent connection
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROVEO 8 Ophthalmic Microscope System optical instrument for improving the
The Issue: The observed issues can lead to unexpected interruptions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit
The Issue: The Quality Control Certificate for certain AutoDELFIA Neonatal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard Custom Surgical Pack Packs contain surgical instruments and accessories
The Issue: Resource Optimization & Innovation, LLC (ROi) received a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD(TM) Medication Cassette Reservoir with clamp and female Luer.
The Issue: Smiths Medical became aware that certain Non Flow-Stop
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD(TM) Medication Cassette Reservoir with clamp and female Luer. Nonvented
The Issue: Smiths Medical became aware that certain Non Flow-Stop
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD(TM) Yellow Medication Cassette Reservoir with clamp and female Luer.
The Issue: Smiths Medical became aware that certain Non Flow-Stop
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GORE TAG
The Issue: Incomplete and/or partial deployment of the CTAG Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prevent G Safety Winged Blood Collection Set Glide - Rx
The Issue: Complain due to the hub needle came out
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO
The Issue: Leaks complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Auriga XL 4007 Laser System
The Issue: Certain Auriga consoles have incorrectly assembled trigger wire
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
The Issue: This product is not meeting the current storage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Auriga 30 Laser System
The Issue: Certain Auriga consoles have incorrectly assembled trigger wire
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
The Issue: This product is not meeting the current storage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.