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 12201–12220 of 38,428 recalls
Recalled Item: Lingen SAMPLE Disposable Virus Sampling Kit pack
The Issue: No 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lingen Disposable Virus Sampling Kit
The Issue: No 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical coagulation
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infant Heel Warmer with Attachment Tab
The Issue: A caution statement is being added to remind
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infant Heel Warmer without Attachment Tab
The Issue: A caution statement is being added to remind
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Avanti¿+ Catheter Sheath Introducer - Product Usage: Is indicated for
The Issue: The product in the packaging is larger (both
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MaxPlusTM bi fuse extension set with 2 clear needleless connectors
The Issue: A portion of a validation lot was inadvertently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 728333 Spectral CT 7500 -Computed Tomography X-ray system
The Issue: When setting patient weight unit preferences to pounds,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 728332 IQon Spectral CT-Computed Tomography X-ray system
The Issue: When setting patient weight unit preferences to pounds,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog
The Issue: intermittent failure causes a blender initialization fault upon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 728327 Ingenuity CT Upgrades-Computed Tomography X-ray system
The Issue: When setting patient weight unit preferences to pounds,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance...
The Issue: When setting patient weight unit preferences to pounds,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography...
The Issue: When setting patient weight unit preferences to pounds,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation (Radiation Treatment Planning System) : RayStation 9A
The Issue: Initial delivery positions will be set incorrectly when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent
The Issue: During stent graft deployment, the radiopaque (RO) marker
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent
The Issue: During product complaint investigation, it was determined that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 /
The Issue: Due to real-time stability study failures resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143
The Issue: Due to real-time stability study failures resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: reSET-O Mobile App
The Issue: Due to a software issue, patients with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: reSET Mobile App
The Issue: Due to a software issue, patients with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.