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 10581–10600 of 38,428 recalls
Recalled Item: Ratcheting Screwdriver Handle
The Issue: The device is unable to meet sterilization requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NIM Vital Console 4.0 (P/N: NIM4CM01) NIM with Software version 1.3.2
The Issue: Software anomaly was identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clean Catch Urine Kit NS 178489
The Issue: Affected products were assembled off-site by individuals who
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nasopharyngeal sample collection tray for COVID-19 testing
The Issue: Affected products were assembled off-site by individuals who
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow-c Anesthesia System : intended for use in administering anesthesia
The Issue: for crack to form on the on/off
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flow-e Anesthesia System : Intended for use in administering anesthesia
The Issue: for crack to form on the on/off
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adult Cap-ONE Biteblock The cap-ONE Biteblock is intended
The Issue: Due to products being shipped/distributed to customers after
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NIM EMG Endotracheal Tube
The Issue: The firm received reports of events related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NIM CONTACT EMG Endotracheal Tube
The Issue: The firm received reports of events related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NIM EMG Endotracheal Tube
The Issue: The firm received reports of events related to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTERGARD Woven Vascular Graft is a woven polyester graft coated
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
The Issue: Isopure received a report of a hazardous incident
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Radiology RA600
The Issue: for Distance and Area measurements to display
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Universal Viewer Zero Footprint Client
The Issue: for Distance and Area measurements to display
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Enterprise Web
The Issue: for Distance and Area measurements to display
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Cardiology CA1000
The Issue: for Distance and Area measurements to display
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS RA1000
The Issue: for Distance and Area measurements to display
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FIRMap" Catheter
The Issue: Incorrect product labeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X80 RADiant Photoelectric Therapy System
The Issue: There is a potential compatibility issue with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIUM DETACHABLE COIL SYSTEM
The Issue: Due to incorrect size and configuration labeling of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.