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 1401–1420 of 38,428 recalls
Recalled Item: Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.
The Issue: Osstem Implant Co. Ltd, is voluntarily initiating a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.
The Issue: Osstem Implant Co. Ltd, is voluntarily initiating a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.
The Issue: Osstem Implant Co. Ltd, is voluntarily initiating a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GORE ACUSEAL Vascular Graft
The Issue: Reports of vascular graft delamination, which may lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M
The Issue: Devices were distributed with incorrect label without CE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sonesta Product Name: 6210 Model/Catalog Number: 0120-LA120-03 Software
The Issue: Video fluoroscopy table may contain inadequate weld on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAC VU360 Acquisition Trunk Cable and Module Holder
The Issue: If a user incorrectly places the Acquisition Module
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MyDay Toric
The Issue: One lot manufactured with an invalid sterilization cycle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Voyant 1-Day Premium Toric
The Issue: One lot manufactured with an invalid sterilization cycle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sofmed Breathables
The Issue: One lot manufactured with an invalid sterilization cycle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Kits: 1) VALVE PACK-LF
The Issue: The kits contain certain lots of cannula products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Venclose digiRF Generators
The Issue: Software version 3.35 of the Venclose digiRF Generator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Frontier Devices
The Issue: Labeling includes shelf life that has not been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-STAT EG6+ cartridge. List Number: 03P77-25.
The Issue: Lack of a 510(k) premarket clearance for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Frontier Devices
The Issue: Labeling includes shelf life that has not been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-STAT CG4+ cartridge (white). List Number: 03P85-25.
The Issue: Lack of a 510(k) premarket clearance for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Frontier Devices
The Issue: Labeling includes shelf life that has not been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914
The Issue: Lack of a 510(k) premarket clearance for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Frontier Devices
The Issue: Labeling includes shelf life that has not been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Frontier Devices
The Issue: Labeling includes shelf life that has not been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.