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 21221–21240 of 38,428 recalls
Recalled Item: Unify Quadra
The Issue: The firm is releasing new firmware for high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quadra Assura MP
The Issue: The firm is releasing new firmware for high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Promote
The Issue: The firm is releasing new firmware for high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ellipse
The Issue: The firm is releasing new firmware for high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Current
The Issue: The firm is releasing new firmware for high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Promote Quadra
The Issue: The firm is releasing new firmware for high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unify Assura
The Issue: The firm is releasing new firmware for high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quadra Assura
The Issue: The firm is releasing new firmware for high
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMENDIA Omega Lumbar Interbody Fusion Device
The Issue: Omega LIF interbody implants labeled as having 11
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE Revision CRS Femoral RT SZ 5 Cemented
The Issue: There may be burrs on the extraction hole
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter
The Issue: Device is at risk of having detectable levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter
The Issue: Device is at risk of having detectable levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE Revision CRS Femoral LT SZ 5 Cemented
The Issue: There may be burrs on the extraction hole
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter
The Issue: Incorrect product labeling. Product labeled as 6mm x
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merlin PCS Programmer software model 3330
The Issue: Devices inappropriately displayed a low battery indicator determined
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump
The Issue: The bezel manufacturing process for the FR-110 plastic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CSI
The Issue: The pumps may switch to stand-by during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Syringe Infusion Pump
The Issue: Certain Barrel Clamp Guides may contain a ridge
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nitinol Staple
The Issue: During a retrospective review of sterilization records, TriMed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nitinol Staple
The Issue: During a retrospective review of sterilization records, TriMed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.