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 26601–26620 of 38,428 recalls
Recalled Item: Brilliance CT Big Bore Oncology
The Issue: After upgrading to 3.6.7 software version via FCO72800643,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed
The Issue: After upgrading to 3.6.7 software version via FCO72800643,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 16
The Issue: After upgrading to 3.6.7 software version via FCO72800643,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core
The Issue: After upgrading to 3.6.7 software version via FCO72800643,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core128
The Issue: After upgrading to 3.6.7 software version via FCO72800643,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OraQuick Ebola Rapid Antigen Test
The Issue: Failed stability testing at 8 months. This lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra External Fixation System Universal Wire Fixation Bolt - 17.5
The Issue: Through the investigation of reported complaints Integra verified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra External Fixation System Slotted Post - Small Catalogue #12224228
The Issue: Through the investigation of reported complaints Integra verified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery
The Issue: Incorrect drill protocol in the Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endura MD Mass Spectrometer u using software versions Endura MD
The Issue: Thermo Fisher has determined that the Endura MD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN:
The Issue: Sterility compromised due to breach in sterile packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TIGR Matrix Surgical Mesh
The Issue: Novus Scientific is implementing additions to the product's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MultiDiagnost Eleva
The Issue: The two bolts that attach the clamping plate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UroDiagnost
The Issue: The two bolts that attach the clamping plate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MultiDiagnost Eleva with Flat Detector
The Issue: The two bolts that attach the clamping plate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RESPONSIVE
The Issue: The alpha total knee replacement components that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TIBIAL TRAY
The Issue: The alpha total knee replacement components that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NOMAD Pro Packaged X-Ray System
The Issue: Firm received customer complaints where end users reported
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NOMAD Pro2 Packaged X-Ray System
The Issue: Firm received customer complaints where end users reported
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TIBIAL TRAY
The Issue: The alpha total knee replacement components that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.