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 3561–3580 of 38,428 recalls
Recalled Item: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600
The Issue: The Atlan anesthesia workstation either indicated a failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500
The Issue: The Atlan anesthesia workstation either indicated a failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models:
The Issue: Within the Irish Market, that a Field Safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED
The Issue: Within the Irish Market, that a Field Safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models:
The Issue: Within the Irish Market, a Field Safety Notice
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models:
The Issue: Within the Irish Market, that a Field Safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Approach CTO Micro Wire Guide
The Issue: Devices from the affected device lots have labels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4.5 x 180 mm Aggressive Cutter
The Issue: Due to holes detected in the inner barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively...
The Issue: May Generate Negatively Biased Results When Testing Samples
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hillrom Welch Allyn Vision Express Holter Analysis System
The Issue: There is the potential for exam files being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System
The Issue: There is the potential for exam files being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio)
The Issue: There is the potential for exam files being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System
The Issue: There is the potential for exam files being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hillrom Welch Allyn HScribe Holter System
The Issue: There is the potential for exam files being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hillrom Welch Allyn XScribe Cardiac Stress Testing System
The Issue: There is the potential for exam files being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioZorb Marker. Radiographic soft tissue marker.
The Issue: Firm received reports of adverse events/complications that include
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to
The Issue: A software issue affecting Philips Vue PACS may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific POLARx BALLOON CATHETER LT 28MM OUS
The Issue: Boston Scientific is updating the instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific POLARx FIT BALLOON CATHETER ST US
The Issue: Boston Scientific is updating the instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific POLARx FIT BALLOON CATHETER LT US
The Issue: Boston Scientific is updating the instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.