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 11061–11080 of 38,428 recalls
Recalled Item: BARD SURESTEP INTERMITTENT CATHETER TRAY
The Issue: There is a potential to leak from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD SURESTEP INTERMITTENT CATHETER TRAY
The Issue: There is a potential to leak from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: E25Bio COVID-19 Direct Antigen Rapid Test
The Issue: The Test is not authorized, cleared, or approved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoolSeal Generator
The Issue: A potential manufacturing/assembly defect could result in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: meridian bioscience immunocard STAT! Rotavirus test
The Issue: The product was incorrectly shipped at room temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Matrix Clinical Solution At-Home COVID-19 Test
The Issue: Due to COVID-19 Test not being authorized for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntraSight Mobile IVUS Systems
The Issue: Multi-Modality Touch Screen Modules (MM-TSM), which are bedside/secondary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Plus Ventilator Part Number 1138747
The Issue: A limited number of ventilators were assembled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator Part Number 1053617
The Issue: A limited number of ventilators were assembled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. Arterial Line Kit 20ga x 6" 2. Arterial Line Kit /1 20ga x 6"
The Issue: Guidewire included with two lots of Arterial Line
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Cranial Access Kits- indicated when a craniotomy is required
The Issue: Incorrect extended expiration dates identified on the outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Cranial Access Kits- indicated when a craniotomy is required
The Issue: Incorrect extended expiration dates identified on the outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip
The Issue: A risk for product contamination was identified for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1. Footrest ( use exclusively in combination with Intelli-C devices)
The Issue: Friction rubber block in the clamping mechanism was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in
The Issue: Laparoscopic devices have a sterile symbol included on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503
The Issue: Laparoscopic devices have a sterile symbol included on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QMS Tacrolimus Immunoassay CALIBRATOR SET QMS TACROLIMUS CAL
The Issue: Due to QMS Tacrolimus Calibrator recovering between 82
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Sight OLO device is a computer vision based platform
The Issue: In instances where custom reference ranges were configured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BenchMark ULTRA and DISCOVERY ULTRA Instruments
The Issue: for Fluid Leak inside a staining system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.