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 26621–26640 of 38,428 recalls
Recalled Item: TIBIAL TRAY
The Issue: The alpha total knee replacement components that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BVX-450NR Bovie Precise 360 Handpiece 45cm
The Issue: The adhesive may be inadequately applied or the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RESPONSIVE
The Issue: The alpha total knee replacement components that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BVX-330BR Bovie Precise 360 Handpiece 33cm
The Issue: The adhesive may be inadequately applied or the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BVX-450BR Bovie Precise 360 Handpiece 45cm
The Issue: The adhesive may be inadequately applied or the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BVX-330NR Bovie Precise 360 Handpiece 33cm
The Issue: The adhesive may be inadequately applied or the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RESPONSIVE
The Issue: The alpha total knee replacement components that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TIBIAL TRAY
The Issue: The alpha total knee replacement components that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RESPONSIVE
The Issue: The alpha total knee replacement components that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xpert MRSA Catalog GXMRSA-120
The Issue: Internal investigation found the certain lots of MRSA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD)
The Issue: Internal review found that some vials of CD3/CD4/CD45
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S7 MACH FrameLink. The software application is sent in CD format with an IFU
The Issue: Medtronic Navigation, Inc. announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FrameLink. The software application is sent in CD format with an IFU
The Issue: Medtronic Navigation, Inc. announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synergy Cranial S7. The software application is sent in CD format with an IFU
The Issue: Medtronic Navigation, Inc. announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fusion ENT Application. The software application is sent in CD
The Issue: Medtronic Navigation, Inc. announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synergy Spine. The software application is sent in CD format with an IFU
The Issue: Medtronic Navigation, Inc. announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MACH AxiEM Cranial Treon. The software application is sent in
The Issue: Medtronic Navigation, Inc. announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MACH Cranial Treon. The software application is sent in CD format with an IFU
The Issue: Medtronic Navigation, Inc. announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Made Tracheostomy Device The CADD Administration Sets with Flow
The Issue: Smiths Medical determined that a single custom Tracheostomy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical...
The Issue: Roche has received four reports of injury caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.