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 7161–7180 of 38,428 recalls
Recalled Item: Aptima CMV Quant Assay
The Issue: Use of assay along with plasma specimen may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS-IW with Universal Viewer
The Issue: GE HealthCare has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Universal Viewer
The Issue: GE HealthCare has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS-IW
The Issue: GE HealthCare has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker
The Issue: Expired product distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BREG WALKER FOLDING WALKER WITH WHEELS Utilized as
The Issue: Due to walkers not meeting product specifications. Walkers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance
The Issue: Housing Mount Jaw of these devices breaking during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Astral 100 and Astral 150 ventilators
The Issue: If ventilator is on internal battery, not intended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack
The Issue: Syringe contains conical tip that is not compatible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Lipase Slides
The Issue: Products 1668409 and 8297749 may contain VITROS Lipase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray
The Issue: Software issue for Cios Alpha, Cios Flow, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System
The Issue: Software issue for Cios Alpha, Cios Flow, and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayCare 5B and 6A including service packs- An oncology information
The Issue: An issue was found in RayCare 5B, 6A,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THUNDERBEAT
The Issue: Thunderbeats blue seal button may remain in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxI 9000 Access Immunoassay Analyzer
The Issue: The firm has investigated and confirmed that when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THUNDERBEAT
The Issue: Thunderbeats blue seal button may remain in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BACTEC Plus Aerobic/F Culture Vials
The Issue: Certain vials of the BD BACTEC" Plus Aerobic/F
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Spetzler-Malis Bipolar forceps
The Issue: An error was identified on the expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Spetzler-Malis Bipolar forceps
The Issue: An error was identified on the expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Spetzler-Malis Bipolar forceps
The Issue: An error was identified on the expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.