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 2641–2660 of 38,428 recalls
Recalled Item: Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet)
The Issue: The A549 human cell target (human cells for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lazervida 10W diode laser cutter and engraver with Lazervida shield.
The Issue: Lazervida 10W Diode Laser Engraver does not fully
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERICIS
The Issue: When following a specific less typical workflow in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Cardio
The Issue: When following a specific less typical workflow in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wayson Hydrocolloid Models: 1) MJ BANDAGE HYDROCOLLOID HEEL OVAL 6CT
The Issue: There is a potential for the sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wayson Hydrocolloid Models: 1) Model Number: CUR5103
The Issue: There is a potential for the sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Centricity Cardiology CA1000 (CA1000)
The Issue: There is a potential security vulnerability in Centricity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Centricity Centricity PACS-IW with Universal Viewer
The Issue: There is a potential security vulnerability in Centricity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Centricity Radiology RA600 (RA600)
The Issue: There is a potential security vulnerability in Centricity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Centricity PACS-IW (PACS-IW)
The Issue: There is a potential security vulnerability in Centricity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Centricity Universal Viewer (UV)
The Issue: There is a potential security vulnerability in Centricity
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CVAC Aspiration System
The Issue: Aspiration system, for endoscopic examination/treatment of urinary tract
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERICIS
The Issue: When following a specific less typical workflow in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERICIS
The Issue: When following a specific less typical workflow in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERICIS
The Issue: When following a specific less typical workflow in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MIM software
The Issue: In situations where two images with differing Fields
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Revolution Apex
The Issue: GE HealthCare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris Systems Manager
The Issue: Software issue that may result in outdated automated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Revolution Apex Select
The Issue: GE HealthCare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Revolution CT
The Issue: GE HealthCare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.