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 8581–8600 of 38,428 recalls
Recalled Item: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X
The Issue: Additional Label Warnings: Amendment / reinforcement of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS one with a hybrid cable- An angiography system developed
The Issue: Examination room monitor connected with the hybrid cable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813
The Issue: Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814
The Issue: Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pressing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DERMLITE DL4W
The Issue: Incorrect labeling; Package labeling contains a different serial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack
The Issue: ExataMed 20 mL oral dispenser component of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectral CT 7500 Computed Tomography X-Ray System
The Issue: Pressing the Unload Pedal of the foot switch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Steris Lighting and Visualization Systems
The Issue: Light handle covers may separate from the light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Steris Lighting and Visualization Systems
The Issue: Light handle covers may separate from the light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery. It
The Issue: Device suddenly and forcefully disassembled after cryotherapy, potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic SenSight Extension Tunneler Kit
The Issue: Medtronic has received reports of SenSight Extension Tunneler
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integre Pro Yellow LP561
The Issue: When using a Laser-Indirect-Ophthalmoscope (LIO) as the delivery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM Cortisol 50T (Material Number 10995538)
The Issue: There is a negative bias with urine patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Cortisol 50T (Material Number 10994924)
The Issue: There is a negative bias with urine patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Carefusion V. Mueller Graves Vaginal Speculum
The Issue: A portion of the two products were incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JULIET Ti LL
The Issue: JULIET Lateral Lumbar Ti-Life Plate, a component of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter Access Free T3
The Issue: The reagent lot produces elevated results (approximately >30%)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF)
The Issue: shearing of the disposable blade may occur
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HAMILTON-C6
The Issue: Software error causes, safety ventilation, in which ventilation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantum Perfusion Systems for CPB
The Issue: The ratchet and pawl had an out of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.