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 35401–35420 of 38,428 recalls
Recalled Item: Integra Licox Brain Tissue Oxygen Monitoring 1 x Complete Brain
The Issue: Integra LifeSciences Corporation has determined that there is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Licox Brain Tissue Oxygen Monitoring
The Issue: Integra LifeSciences Corporation has determined that there is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography...
The Issue: The Instructions for Use (IFU) for the MobileDiagnost
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Flexible Medullary Reamer. Intended to be used to facilitate
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sodium Bicarbonate
The Issue: Church and Dwight Co., Inc. has initiated a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bigliani/Flatow¿ The Complete Shoulder Solution
The Issue: The firm is initiating a removal of one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioDynamics RITA Main Cable
The Issue: The RITA Main Cable product contains the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional
The Issue: Zimmer had received complaints that reported breakage of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona (TM) The Personalized Knee System PS Tibial Articular Surface
The Issue: Zimmer had received complaints that reported breakage of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional
The Issue: Zimmer had received complaints that reported breakage of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona (TM) The Personalized Knee System CPS Tibial Articular Surface
The Issue: Zimmer had received complaints that reported breakage of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona (TM) The Personalized Knee System CR Tibial Articular Surface
The Issue: Zimmer had received complaints that reported breakage of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona (TM) The Personalized Knee System UC Tibial Articular Surface
The Issue: Zimmer had received complaints that reported breakage of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: pO2 D999 membrane units. Distributed by Radiometer America
The Issue: RADIOMETER became aware that the regarded lot pO2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to
The Issue: Baxter Healthcare Corporation issued an Urgent Device Correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm
The Issue: One of the dental implants do not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product
The Issue: One of the dental implants do not have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Steam Biological Indicators
The Issue: Mesa Labs, based out of Bozeman, MT, informed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Steam Biological Indicator
The Issue: Mesa Labs, based out of Bozeman, MT, informed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack
The Issue: Mesa Labs, based out of Bozeman, MT, informed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.