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 26501–26520 of 38,428 recalls
Recalled Item: Radial Artery Catheterization Kit with Sharps Safety Features Permits access
The Issue: Shipping carton labeling error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanguard 360 Revision Knee System Knee prostheses
The Issue: The drill bit used to drill the hex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Centaur¿ Calibrator U
The Issue: Failure of analytical sensitivity with Calibrator U kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Syringe Module Model 8110 with software version 9.15 The
The Issue: A software anomaly with the Alaris Syringe module
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3I OSSEOTITE CERTAIN DENTAL IMPLANTS
The Issue: Product was incorrectly packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arterial Line Catheterization Kit with Sharps Safety Features Permits access
The Issue: Shipping carton labeling error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System.
The Issue: There is a possibility of specimen misidentification for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPECULAR MICROSCOPE CEM-530
The Issue: Software version 1.08 and 1.09 for the Specular
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer Push Button Blood Collection Set
The Issue: Becton Dickinson is recalling various lot numbers of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235 The PTS is a medical device designed to
The Issue: IBA is recalling to provide information through a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareLink iPro Version 1.10
The Issue: Medtronic MiniMed is recalling the CareLink iPro Therapy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.x picture archiving and communication system Syngo.x is a software
The Issue: Software error. Incorrect values for the volume calculation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.via picture archiving and communication system Syngo via is a
The Issue: Software error. Incorrect values for the volume calculation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nylon Surgical Suture for human use and vet use
The Issue: Nylon Surgical Sutures are recalled because the seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: e.cam and Symbia E gamma camera systems with patient beds
The Issue: "We have received reports of patients hair being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polypropylene Surgical Sutures
The Issue: Polypropylene Surgical Sutures are recalled because the seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infant Warmer System (IWS)
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MISAGO RX Self Expanding Peripheral Stem
The Issue: During recent routine testing, the MISAGO Peripheral Stent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirStrip Sense4Baby Model C Fetal Monitor The Sense4Baby System Model
The Issue: Belt clip may become detached causing electronic components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System
The Issue: Beckman Coulter is recalling the UniCel DxH Slidemaker
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.