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 31121–31140 of 38,428 recalls
Recalled Item: Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
The Issue: Power supply malfunction complaints related to suboptimal thermal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Precise Treatment Table
The Issue: It is possible to position the Treatment Table
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9F Plastic Dual Port
The Issue: The dual port with catheters was not covered
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis
The Issue: An increase in complaints of loosening and radiolucent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare XPREZZON Bedside Monitor
The Issue: Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare qube Compact Monitor
The Issue: Spacelabs Healthcare qube Bedside Monitors, Model 91390, are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Engstrom Carestation
The Issue: failure of the caster mounting hardware, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Systems Progesterone Kit
The Issue: ADVIA Centaur Systems Progesterone Kit Lots Ending in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Systems Progesterone Kit
The Issue: ADVIA Centaur Systems Progesterone Kit Lots Ending in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Systems Progesterone Kit
The Issue: ADVIA Centaur Systems Progesterone Kit Lots Ending in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediChoice WarmGel Infant Heel Warmer
The Issue: Products without expiration date have the remote potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CooperSurgical Infant Heel Gel Warmers
The Issue: Products without expiration date have the remote potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fisher Brand Gel Infant Heel Gel Warmers
The Issue: Products without expiration date have the remote potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NovaPlus Brand Warm Gel Infant Heel Gel Warmer
The Issue: Products without expiration date have the remote potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Haemonetics TEG Hemostasis System Level II Control
The Issue: Specific lots of Level II Control Kits produce
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-MAC Cannula (Needle) Set
The Issue: Devices are misbranded - failure to properly classify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-CORE Cannula (Needle) Set
The Issue: Devices are misbranded - failure to properly classify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-PLASTY Cannula (Needle)
The Issue: Devices are misbranded - failure to properly classify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Passport V Monitor
The Issue: An issue has been identified with Passport V
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAX-TL 9.0 x 7.0 mm Implant
The Issue: Z-MAX Implant, 9mm diameter, 7mm length labeled package,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.