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 30061–30080 of 38,428 recalls
Recalled Item: MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
The Issue: A diaphragm size 80 labeled box was incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pointe Scientific G6PD Controls Kit configuration: 6 x 0.5 ml
The Issue: A reduction in the reconstituted stability has been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Tni-Ultra Assay
The Issue: System-to-system bias between the Tni-Ultra assay on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VersaTREK Instrument Series 240
The Issue: Use of the recalled product may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CentraLink" Data Management System
The Issue: Siemens Healthcare Diagnostics has determined that the sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VersaTREK Instrument Series 528
The Issue: Use of the recalled product may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The VariSource iX series afterloader systems are computer controlled remote
The Issue: After an application freeze and restart of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
The Issue: Varian has discovered that there is a discrepancy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ClearSight
The Issue: Edward Lifesciences is recalling the ClearSight System because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: M/L Taper with Kinectiv¿ Technology. prosthesis
The Issue: Zimmer is initiating a voluntary recall of 64
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ally Uterine Positioning System (Ally UPS) used in the mounting
The Issue: Design of device may expose user to injury
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in
The Issue: Coreva Health Science, LLC. is recalling ActCel Hemostatic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5
The Issue: Vial to vial variation in the fill volume
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cell Search Circulating Tumor Kit. Intended for the enumeration of
The Issue: Complaints of the presence of artifacts that appears
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gelseal Straight Diameter 8mm Length 30cm. Vascular graft prosthesis is
The Issue: Product was labeled as a 30cm graft, when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gelseal Straight Diameter 8mm Length 15cm. Vascular graft prosthesis is
The Issue: Product was labeled as a 30cm graft, when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVAC 70 XTRA with Integrated Cable Product Usage:
The Issue: component failure causing device inoperability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROcise XP Wand with Integrated Cable Product Usage:
The Issue: component failure resulting in inoperability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Ultrasound
The Issue: Philips Healthcare has discovered a problem in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.