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 1561–1580 of 38,428 recalls
Recalled Item: Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x
The Issue: Philips Azurion and Allura systems configured with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled
The Issue: that a component (air baffle) may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures
The Issue: Specific lots of reprocessed electrophysiology and ultrasound catheters
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers...
The Issue: Specific lots of reprocessed electrophysiology and ultrasound catheters
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological...
The Issue: Specific lots of reprocessed electrophysiology and ultrasound catheters
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording...
The Issue: Specific lots of reprocessed electrophysiology and ultrasound catheters
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and...
The Issue: Specific lots of reprocessed electrophysiology and ultrasound catheters
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LinkSymphoKnee System
The Issue: Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product
The Issue: The potential of the elastic bands included in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPLANT EPIKUT PLUS MT16 3
The Issue: Dental implants were imported under temperature and storage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fortress Introducer Sheath System Product Name: Fortress Introducer
The Issue: Units may have been packaged with an incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clearview Strep A Exact II Dipstick Respiratory Kit
The Issue: Due to a classification error in the inventory
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales
The Issue: VITROS Chemistry Products LAC Slides on VITROS XT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit
The Issue: VITROS Chemistry Products LAC Slides on VITROS XT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WATCHMAN TruSeal Access System SGL
The Issue: Boston Scientific has identified a higher likelihood of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WATCHMAN FXD Curve Access System Dbl
The Issue: Boston Scientific has identified a higher likelihood of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WATCHMAN TruSeal Access System DBL
The Issue: Boston Scientific has identified a higher likelihood of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WATCHMAN FXD Curve Access Sys Sgl
The Issue: Boston Scientific has identified a higher likelihood of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WATCHMAN TruSeal Access System DBL
The Issue: Boston Scientific has identified a higher likelihood of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WATCHMAN FXD Curve Access Sys Dbl
The Issue: Boston Scientific has identified a higher likelihood of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.