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 10661–10680 of 38,428 recalls
Recalled Item: Crome Models loaded with CareLink SmartSync Device Manager application software
The Issue: Telemetry error that may occur with Medtronic Cobalt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt Models loaded with CareLink SmartSync Device Manager application software
The Issue: Telemetry error that may occur with Medtronic Cobalt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis icono biplane -angiography systems developed for single and biplane
The Issue: if the protective earth is interrupted and an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis icono floor-angiography systems developed for single and biplane...
The Issue: if the protective earth is interrupted and an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AC-powered adjustable medical beds with built-in electric DC actuators and
The Issue: There is a potential hazard of uninterrupted motion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AC-powered adjustable medical beds with built-in electric DC actuators and
The Issue: There is a potential hazard of uninterrupted motion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Gibeck Humid-Vent 2S Flex DC
The Issue: Reports received of torn corrugated breathing tubes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Teleflex Flex tube
The Issue: Reports received of torn corrugated breathing tubes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
The Issue: Firm distributed tests which have not been cleared
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit
The Issue: Firm distributed tests which have not been cleared
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XVIVO Organ Chamber
The Issue: The weld seal of the primary pouch was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiometer
The Issue: Arterial Blood Sampler sterility cannot be guaranteed throughout
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemosIL ReadiPlasTin
The Issue: Variable and out of specification QC results with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TMJ Arthroscopy Drape
The Issue: Latex content in product was labeled incorrectly as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NanoSight NS300
The Issue: Product found to not comply to Class 1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Resin UPDATE CD-ROM
The Issue: The problem is with the Bio-Rad VARIANT nbs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radial Head Replacement System Implant is a one-piece
The Issue: DePuy Synthes Radial Head Replacement System Contraindications added
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: V8 Immunodisplacement Kit
The Issue: Due to microbial growth causing interference with interpretation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accula SARS-CoV-2 Test
The Issue: SARS-CoV-2 Test has an increased potential for false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRAY RING COVER
The Issue: breach in the sterility barrier for tray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.