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 34481–34500 of 38,428 recalls
Recalled Item: GE Healthcare Discovery NMCT 670
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD
The Issue: Kimberly-Clark Single Shot Epidural Pain Management Trays contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-Series: Clinac
The Issue: This correction is to notify users that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fixed Offset Adapter
The Issue: Ossur inititated a voluntary recall of the A-642100
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Osseocare Pro Console & Set Osseocare Pro
The Issue: The recall was initiated because there is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView XCT is a gamma camera for Single Photon Emission
The Issue: It was discovered the CT portion of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any
The Issue: A safety risk regarding a potentially existing dark
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS brand ONCOR series Linear Accelerator Linac systems with component:
The Issue: A safety risk regarding a potentially existing dark
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vascutek Gelsoft Vascular Graft (peripheral) Labeling reads in part
The Issue: Terumo Cardiovascular Systems (Terumo CVS) became aware of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Brand Name(s): Alere Cholestech LDX¿ Lipid Profile"GLU Test Cassette
The Issue: Alere initiated a recall of Cholestech LDX Lipid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTRUS¿ THERMAL TISSUE FUSION
The Issue: The affected lots were exposed to a higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zeiss brand IOLMaster 500
The Issue: The user database delivered for download contained an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zeiss brand IOLMaster
The Issue: The user database delivered for download contained an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTRUS¿ THERMAL TISSUE FUSION
The Issue: The affected lots were exposed to a higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model FL14E Rose BedsThe Rose Bed is an AC-powered adjustable
The Issue: It was reported that the siderail may appear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ray Station Radiation Therapy Treatment Planning System
The Issue: Ray Search Laboratories found an issue with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns" Venous Return Cannulae
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns" Soft-Flow¿ Aortic Cannula without Suture Flange
The Issue: During an in-process inspection, Terumo Cardiovascular Systems (Terumo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.