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 11521–11540 of 38,428 recalls
Recalled Item: MobileDiagnost wDR
The Issue: While cleaning or disinfecting the system, if the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: These are communication systems
The Issue: An unrecoverable error may occur where a component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NuStat 8" x12" Trauma Pad XR Hemafiber
The Issue: Endotoxin levels exceeded allowable limits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHIP KIT
The Issue: Top label of the outer package of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T4 EIA Kit
The Issue: Immunoassay TEST Kit do not meet product shelf-life
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IPL Coupling Gel
The Issue: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
The Issue: Diagnostic ultrasound system with the specified software version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
The Issue: Diagnostic ultrasound system with the specified software version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
The Issue: Diagnostic ultrasound system with the specified software version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
The Issue: When the ultrasound system is used in combination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Skinny Needle with Chiba Tip. RPN 090010
The Issue: Specific lots may contain black debris on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemosIL ReadiPlasTin (20 mL)
The Issue: The firm has received customer reports of performance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncentra Brachy users using version 4.0 and above with Applicator
The Issue: Under certain circumstances, there can be a difference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Custom Perfusion kits
The Issue: Product is labeled as non-pyrogenic but endotoxin testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis pheno with software VE20C- diagnostic imaging angiography system Model:
The Issue: Four potential software issues with Artis pheno and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis icono biplane with software VE20C-diagnostic imaging angiography...
The Issue: Four potential software issues with Artis pheno and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis icono floor with software VE20C-diagnostic imaging angiography system...
The Issue: Four potential software issues with Artis pheno and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic CareLink SmartSync Device Manager application software (D00U005)...
The Issue: The processing of collected episode data may fail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affected components are limited to the Monoprice charging cable (Product
The Issue: Warning Added: Using damaged cables or chargers, or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bartels Legionella Urinary Antigen- an adjunct to culture for the
The Issue: Contamination of the conjugate may cause a pipetting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.