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 3001–3020 of 38,428 recalls
Recalled Item: NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C
The Issue: It was identified internally that two commingle events
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VARIPULSE Bi-Directional Ablation Catheter . The Field Catheter is
The Issue: Due to an observed trend of neurovascular events
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Irix-A Integrated Lumbar Fusion System
The Issue: Certain implants in the Irix-A Lumbar Fusion System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline RR-LIVER TRNS ACCESSORY PEDS
The Issue: Medline is recalling medical convenience kits which were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SenTiva" Product Name: VNS Therapy" SenTiva"
The Issue: Their is a potential that implanted pulse generators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO"
The Issue: Their is a potential that implanted pulse generators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Socrates 38 Aspiration Catheter 127 cm length The
The Issue: Due to manufacturing non-conformance that resulted in channels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK...
The Issue: Due to devices being irradiated above the established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access PCT Reagent Pack
The Issue: Identified reagent lots are experiencing a high rate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid
The Issue: Disposable set may leak during priming from a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS One Angiographic X-Ray System
The Issue: A potential issue with ARTIS One systems was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL
The Issue: Due to the lack of the Ethylene Vinyl
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novation XLE Item Number / Product Description: 140-22-70 NV EHXL
The Issue: Due to the lack of the Ethylene Vinyl
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL
The Issue: Due to the lack of the Ethylene Vinyl
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY
The Issue: The catheter subassembly in the Integrated Arterial Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT
The Issue: The catheter subassembly in the Integrated Arterial Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeiMed NasoGel for DRY NOSES UDI-DI/code: 00705928045309 SKU GSP30-2R-48-ENU-USL
The Issue: Due to nasal spray stability failure for bioburden
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: regard Item Number: 830106006
The Issue: There is a potential for the Inline Controller
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AnchorFast SlimFit
The Issue: Hollister received reports of decreased skin barrier wear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AnchorFast
The Issue: Hollister received reports of decreased skin barrier wear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.