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 18921–18940 of 38,428 recalls
Recalled Item: Kii Fios First Entry
The Issue: The product may not have met sterility requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTEGRA
The Issue: Products were distributed with the incorrect instructions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTEGRA
The Issue: Products were distributed with the incorrect instructions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fetal Spiral Electrode
The Issue: During use of the Philips FSE, it is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Obturator (long cone)
The Issue: The weld may break, resulting in the rod
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Obturator (shortcone)
The Issue: The weld may break, resulting in the rod
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lithium-ion Rechargeable Batteries for the Philips MX40 Wearable Monitor REF:
The Issue: Lithium-ion Rechargeable Batteries for the Philips MX4O Wearable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film
The Issue: Due to an inhomogeneous coating solution, pinholes can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIUS Blower Mister Product Code/: CB-1000 The Axius Blower
The Issue: lack of carbon dioxide (CO2) flow that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Na+ Slides
The Issue: Imprecision in the affected lot may produce negatively
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBRA FUSION 150 Ablation System (International Only)
The Issue: There is a potential for patients undergoing ablation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBRA FUSION 150 Ablation System
The Issue: There is a potential for patients undergoing ablation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBRA FUSION 150 Ablation System
The Issue: There is a potential for patients undergoing ablation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBRA FUSION 50
The Issue: There is a potential for patients undergoing ablation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Edward Lifesciences
The Issue: This action has been initiated to address complaint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instrument Tray
The Issue: The faceplates may incorrectly identify the T2 Basic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revolution CT scanners Product Usage: The system is intended for head
The Issue: Additional low dose radiation exposure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG -
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aircast - PL RX only VF-PL Sterile Cuff Pkg.
The Issue: The product may not meet sterility requirements. Product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage:
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.