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 26941–26960 of 38,428 recalls
Recalled Item: AMD-Ritmed Transparent Dressing - Window with label
The Issue: The lot of transparent dressing was found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peripherally Inserted Central Catheters (PICC)
The Issue: There is a potential for stylet stiffening that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Peripherally Inserted Central Catheters (PICC)
The Issue: There is a potential for stylet stiffening that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist System Controller Product Usage: For use as
The Issue: Loose connector ports in controller body
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns TCM
The Issue: Terumo Cardiovascular Systems (Terumo CVS) is conducting a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Preamendments device-Sarns Dual Cooler-Heater. The Sarns Dual Cooler-Heater is a
The Issue: Terumo Cardiovascular Systems (Terumo CVS) is conducting a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HX2" Temperature Management Systems
The Issue: Terumo Cardiovascular Systems (Terumo CVS) is conducting a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns TCM II
The Issue: Terumo Cardiovascular Systems (Terumo CVS) is conducting a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Free T3 Assay
The Issue: Demonstrate an upward shift in patient results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instructions for Use (IFU) for Progesterone 3 Calibrator Set
The Issue: Instructions For Use had incorrect lot number and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Depuy Synthes Trauma- Trochanteric Fixation Nail Advanced (TFNA) Blade/Screw...
The Issue: DePuy Synthes is initiating a voluntary medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01....
The Issue: Medtronic is recalling all lots of the Covidien
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2
The Issue: Stryker Neurovascular has become aware that some units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL
The Issue: Stryker Neurovascular has become aware that some units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM
The Issue: Stryker Neurovascular has become aware that some units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4
The Issue: Stryker Neurovascular has become aware that some units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3
The Issue: Stryker Neurovascular has become aware that some units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL
The Issue: Stryker Neurovascular has become aware that some units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM
The Issue: Stryker Neurovascular has become aware that some units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.