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 32801–32820 of 38,428 recalls
Recalled Item: IS4000 da Vinci Xi - Endoscope accessory
The Issue: In some procedures when using the endoscope in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Animas Vibe Insulin Infusion Pump. This product is indicated for
The Issue: Animas determined that the Hebrew language translation in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tenor is a mobile passive lift
The Issue: ArjoHuntleigh received reports where the Tenor Lift without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral
The Issue: A complaint was received in which it was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTAMIX 1200 Compounder
The Issue: If the universal ingredient (UI) in an active
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Toe Instrument Kit
The Issue: An oversight in the implementation of the design
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MC-500 Multicolor Laser Photocoagulator
The Issue: Laser aperture label was not affixed to device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coat-A-Count Direct Androstenedione
The Issue: The assay is demonstrating a higher frequency of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Attest Auto-reader. Model numbers 390
The Issue: Labeling on units shipped prior to May 16th,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Duet External Drainage and Monitoring System
The Issue: Medtronic Neurosurgery is recalling the Medtronic Duet External
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MIS Rod 2
The Issue: Integra Lifesciences is recalling NewPort System MIS Rod,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Duet External Drainage and Monitoring System
The Issue: Medtronic Neurosurgery is recalling the Medtronic Duet External
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Duet External Drainage and Monitoring System
The Issue: Medtronic Neurosurgery is recalling the Medtronic Duet External
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Duet External Drainage and Monitoring System
The Issue: Medtronic Neurosurgery is recalling the Medtronic Duet External
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Duet External Drainage and Monitoring System
The Issue: Medtronic Neurosurgery is recalling the Medtronic Duet External
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RT-5100 and RT-3100
The Issue: Near Point Chart Arm of RT 5100 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Medical System Allura Xper X-Ray Angiographic
The Issue: In certain circumstances, a software error can lead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) //
The Issue: Listeria Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Columbia Agar with 5% Sheep Blood Columbia Agar with 5%
The Issue: Listeria Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CDC Anaerobe 5% Sheep Blood Agar CDC Anaerobe 5% Sheep
The Issue: Listeria Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.