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 10781–10800 of 38,428 recalls
Recalled Item: Augustine Surgical Inc. HOT DOG PATIENT WARMING
The Issue: HotDog Temperature Management Controllers Models WC71, WC77, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Augustine Surgical Inc. HOT DOG PATIENT WARMING
The Issue: HotDog Temperature Management Controllers Models WC71, WC77, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hillrom Temperature Management Controller
The Issue: HotDog Temperature Management Controllers Models WC71, WC77, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Augustine Surgical Inc. HOT DOG PATIENT WARMING
The Issue: HotDog Temperature Management Controllers Models WC71, WC77, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Augustine Surgical Inc. HOT DOG PATIENT WARMING
The Issue: HotDog Temperature Management Controllers Models WC71, WC77, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology
The Issue: Atlas Stim Headbox (ASHB) was delivered to US
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cub 2 Enclosed Bed Canopy System
The Issue: Due potential misuse of the product, firm is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Resources International First Aid Kits
The Issue: ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Resources International First Aid Kits
The Issue: ULTRAtab Laboratories recalled Acetaminophen and electrolyte tablets that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VELYS Robotic-Assisted Solution Base Product No.: 451570100
The Issue: System software v1.5.1 has a system software issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Virus Counter Platform with Model Name VC3100
The Issue: The Virus Counter is an automated laboratory instrument
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plus 30 Priority Pack w/.096 RHV - WPL2122277-01
The Issue: Due to an increase in complaint trend for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INDEFLATOR Plus 30 - WPL2122277-01 (2019-03-01)
The Issue: Due to an increase in complaint trend for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20/30 INDEFLATOR - WPL2122268-01 (2019-03-01)
The Issue: Due to an increase in complaint trend for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20/30 Priority Pack Accessory Kit/.096 RHV - WPL2122270-01
The Issue: Due to an increase in complaint trend for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20/30 Priority Pack w/COPILOT - WPL2122272-01 (2019-03-01)
The Issue: Due to an increase in complaint trend for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems
The Issue: There is a quality issue with the three
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
The Issue: Bluetooth malfunction impacting Gallant devices post-implant. The failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
The Issue: Bluetooth malfunction impacting Gallant devices post-implant. The failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merlin 2 PCS MER3700 programmer Model MER3400 software
The Issue: Due to a programmer software anomaly under very
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.