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 21861–21880 of 38,428 recalls
Recalled Item: Brilliance Big Bore (Oncology) - Model no. 728243
The Issue: Closing the Emergency Stop may disable the horizontal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: J-Plasma Precise 360(R)
The Issue: Bovie Medical is issuing a correction to address
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: J-Plasma Precise(R)
The Issue: Bovie Medical is issuing a correction to address
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: J-Plasma(R) Handpiece
The Issue: Bovie Medical is issuing a correction to address
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: J-Plasma Precise(R) OPEN
The Issue: Bovie Medical is issuing a correction to address
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIO CAL(R) Temperature Controller
The Issue: Medtronic has been unable to develop a cleaning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell
The Issue: RBC Reagent failure. High fluorescent counts during RBC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invia Motion Negative Pressure Wound Therapy System. Labeled as: a.
The Issue: Device may display a battery missing error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard Closed Suction System for Adults
The Issue: Certain Flex Connectors supplied with Halyard Closed Suction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard Closed Suction System for Adults
The Issue: Certain Flex Connectors supplied with Halyard Closed Suction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard Closed Suction System for Adults
The Issue: Certain Flex Connectors supplied with Halyard Closed Suction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Human Fetal Hemoglobin (HBF-1) FITC Conjugate
The Issue: Three lots of Human Fetal Hemoglobin FITC Conjugate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VOLISTA StandOP Surgical Light
The Issue: The manufacturer received complaints indicating that the device's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use
The Issue: Update XL¿ device software to version A.03. This
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIM Tibial Nails intramedullary fixation rod - NON-STERILE
The Issue: The AIM Tibial Nails failed a clinical analysis
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIM Tibial Nails intramedullary fixation rod - STERILE
The Issue: The AIM Tibial Nails failed a clinical analysis
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile EXACTAMED Oral Dispenser
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZYMUTEST HIA MonoStria qualitative screening assay intended for the global
The Issue: Incorrect package insert indicating use of the kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZYMUTEST HIA IgGAM
The Issue: Incorrect package insert indicating use of the kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZYMUTEST HIA MonoStrip IgG
The Issue: Incorrect package insert indicating use of the kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.