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 2481–2500 of 38,428 recalls
Recalled Item: Esaote Endocavity ultrasonic probe
The Issue: A potential weakness has been identified in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DORO¿ Easy-Connect Navigation Adaptor
The Issue: of compromised compatibility resulting in influence on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical
The Issue: Update to IFU to provide additional information related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical
The Issue: Update to IFU to provide additional information related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Celsior Cold Storage Solution Product Name: Celsior Cold
The Issue: The potential for risk of microbiological contamination of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate Mobile Power Unit:
The Issue: Left Ventricular Assist System Mobile Power Unit (MPU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus
The Issue: Identified faulty cartridges. If such a faulty cartridge
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novasight Hybrid System Product Name: Novasight Hybrid Catheter
The Issue: Due to manufacturing issues there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VentStar Product Name: VentStar Flex 220 Model/Catalog Number:
The Issue: The potential for cracks forming in the breathing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit
The Issue: The potential for cracks forming in the breathing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit
The Issue: The potential for cracks forming in the breathing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit
The Issue: The potential for cracks forming in the breathing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit
The Issue: The potential for cracks forming in the breathing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit
The Issue: The potential for cracks forming in the breathing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ID Circuit Product Name: ID Circuit Flex 220
The Issue: The potential for cracks forming in the breathing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PYXIS MEDBANK (Name
The Issue: Users trying to restock a single bin location
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD 4 Fr Single-Lumen PowerPICC Catheters
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower
The Issue: Due to a software bug, automated dispensing cabinet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Revised C Reactive Protein (RCRP)
The Issue: Incorrect software flagging may occur for the assay
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID
The Issue: Due to a software issue, when attempting to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.