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 25781–25800 of 38,428 recalls
Recalled Item: Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
The Issue: Disengaged screw head could potentially not be retained
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACTIS Flex Reamers SZ 0/1
The Issue: DePuy Orthopaedics, Inc. is issuing a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan LabPro Data Management System. Intended to manage both microbial
The Issue: Beckman Coulter has received and confirmed reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT
The Issue: Toshiba American Medical Systems (TAMS) is recalling the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OR Table
The Issue: Trumpf has identified six incidents of pinched cables
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd.
The Issue: Ansell Healthcare Products is initiating a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FMsealer Open Shears. Model FM3001
The Issue: Domain Surgical, Inc. announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Ostase Calibrators
The Issue: Beckman Coulter has determined that the Access Ostase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Ostase QC
The Issue: Beckman Coulter has determined that the Access Ostase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for...
The Issue: Incorrectly labeled Manufactured by DiaSorin, The correct term
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for...
The Issue: Incorrectly labeled Manufactured by DiaSorin, The correct term
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: is a qualitative indirect enzyme immunoassay enzyme-linked immunosorbent...
The Issue: Incorrectly labeled Manufactured by DiaSorin, The correct term
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: is a quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for...
The Issue: Incorrectly labeled Manufactured by DiaSorin, The correct term
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total
The Issue: The Main Printed Circuit Board Assembly (PCBA) of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The
The Issue: The kits contain Multi-Med Single Lumen Catheters that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 560 Hematology Systems
The Issue: Siemens is investigating an issue which may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVION S250 Product Usage: Proton Radiation Therapy System
The Issue: Recovery of Incorrect Isocenter -operational change
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NOVAPLUS(R) Pregnancy Cassette Device with Droppers
The Issue: Incorrect hCG results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nordson Micromedics FibriJet Endoscopic Catheter Introducer
The Issue: The sterile packaging may contain small channels in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Force
The Issue: Siemens is providing software update version VA50A_SP3 to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.