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 8941–8960 of 38,428 recalls
Recalled Item: HydroPICC 4Fr Single Lumen
The Issue: Select catheter lots were identified to be labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroMID 4Fr Single Lumen - Basic Kit
The Issue: Select catheter lots were identified to be labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroPICC 4Fr Single Lumen
The Issue: Select catheter lots were identified to be labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mammotome MammoStar Biopsy Site Identified
The Issue: The label incorrectly identifies the product as STAR1401,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovaGuide Intelligent Ultrasound System
The Issue: Transcranial Doppler/ultrasound system tablet has a faulty hard
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System Material # Artis zee floor 10094135 Artis zee ceiling
The Issue: In rare cases, the system may only boot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lucid TCD 2.0 System
The Issue: Transcranial Doppler/ultrasound system tablet has a faulty hard
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS pheno
The Issue: Mechanical connection between the tabletop and table base
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HIGH V+ Spinal Cement System
The Issue: Incorrect expiry date. Product is labeled with expiry
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AxiEM" Non-Invasive Patient Tracker
The Issue: Due to increasing complaint trend for the Non-Invasive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOPSY MEDIUM 10ML
The Issue: The affected product may contain a medium other
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative...
The Issue: Leakage of the original specimen from the plastic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxford Partial Knee System
The Issue: Packaged in the incorrect shelf carton. Incorrect shelf
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McCormick Medical Distribution PORT TRAY
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HCT 12 CC SYRINGE KIT
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HCT 6 CC SYRINGE KIT
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HCT 50mL EVA BAGS
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tacy Medical
The Issue: for the outer bag having pinhole leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.