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 30041–30060 of 38,428 recalls
Recalled Item: PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal
The Issue: Bard Access Systems is recalling PowerPICC Solo Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm
The Issue: certain lots of the Titanium Recon Screws (6.5mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt
The Issue: Integra LifeSciences is recalling the Camino Intracranial Pressure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage:
The Issue: Haptics breaking during lens loading and insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bausch & Lomb SofPort Advanced Optics Aspheric Lens
The Issue: Haptics breaking during lens loading and insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in
The Issue: Medtronic Navigation is initiating a field correction due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD¿- Solis Ambulatory Infusion Pump
The Issue: Smiths Medical has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: American Science & Engineering Inc
The Issue: During factory testing, we discovered that Gemini systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0702-001-350Q
The Issue: Stryker Instruments is initiating a recall of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/ zeego systems
The Issue: There exists a possible position sensor fault in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV...
The Issue: for a leak at the tubing to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Single Barrel Drill Guides The Single Barrel Drill Guide
The Issue: Shipped to a single consignee prior to completion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech Ambassador Cervical Plate System The Exactech Ambassador Cervical Place
The Issue: Shipped to a single consignee prior to completion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Healthcare Diagnostics Dimension Vista Systems
The Issue: Two software issues may occur in Vista software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bullet-Tip PEEK VBR/IBF System
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sure T
The Issue: Unomedical has found that in rare cases the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thoracic Grasper
The Issue: The coating of the 5 mm Thoracic Grasper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncentra Brachy radiation therapy planning software designed to analyze and
The Issue: Incorrect dose calculation for Regions of Interest (ROIs)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NDI Disposable Marker Spheres for Brainlab IGS (Image Guided
The Issue: Inadequate curing of adhesive, which may cause the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for...
The Issue: Bacterial contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.