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 2021–2040 of 38,428 recalls
Recalled Item: Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The
The Issue: Due to a risk of false positive results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inseego USB8 4G Dongle Kit
The Issue: Kit USB flash drive contains outdated software, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hillrom LikoScale component
The Issue: The Q-link 13 could allow for an improper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hillrom Q-Link 13 component
The Issue: The Q-link 13 could allow for an improper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Servo-u Ventilator System. Model Number: 6688600.
The Issue: for inaccurate measurement of the patient circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Servo-n Ventilator System. Model Number: 6694800.
The Issue: for inaccurate measurement of the patient circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Servo-u MR Ventilator System. Model Number: 6888800.
The Issue: for inaccurate measurement of the patient circuit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers
The Issue: Drug Elutable Microspheres have a smaller actual average
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectral CT. Computed tomography X-ray system.
The Issue: Devices with affected software may experience two unintended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Achieva Nova-Dual Product Number: 781173
The Issue: identified an issue where a component failure in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Explorer/Nova Dual Product Number: 781108
The Issue: identified an issue where a component failure in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to dStream for 1.5T¿
The Issue: identified an issue where a component failure in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Achieva IT Nova Product Number: 781175
The Issue: identified an issue where a component failure in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Achieva Nova Product Number: 781172
The Issue: identified an issue where a component failure in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera Achieva 1.5T Pulsar
The Issue: identified an issue where a component failure in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Master/Nova Product Number: 781106
The Issue: identified an issue where a component failure in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Omni/Stellar
The Issue: identified an issue where a component failure in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva XR Product Numbers: (1) 781153
The Issue: identified an issue where a component failure in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips eL18-4 EMT Transducer.
The Issue: Ultrasound transducer devices were refurbished beyond their useful
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips C9-5EC Transducer.
The Issue: Ultrasound transducer devices were refurbished beyond their useful
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.