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 17101–17120 of 38,428 recalls
Recalled Item: Medtronic Micra MC1VR01
The Issue: Medtronic is updating the Micra Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Imactis Navigation Kit
The Issue: The firm has become aware that the sensor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LightPod ERA lasers
The Issue: This relates to the standard 21 CFR 1040.10(f)(3)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LightPod Neo Lasers
The Issue: This relates to the standard 21 CFR 1040.10(f)(3)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rocket KCH Fetal Bladder Drainage Catheter Model: R57405
The Issue: A complaint was received regarding kinking of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gold Cup Leadwire and Snap Leadwire with the following component
The Issue: The electrode lead connector has a protruding conductor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel
The Issue: The mounts on the monitor may have an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration
The Issue: Product Pouches may not be sealed properly and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer¿ Push Button Blood Collection Set with Pre-Attached Holder
The Issue: Separation of front and rear barrels upon activation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C2 Nerve Monitor
The Issue: Stryker C2 NerveMonitor's design and instructions may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C2 Nerve Monitor
The Issue: Stryker C2 NerveMonitor's design and instructions may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HS Hi-R NEO 900A NIR # 657 822 Serial
The Issue: software error in the central control unit of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HS Hi-R NEO 900 # 657 820 Serial #
The Issue: software error in the central control unit of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HS Hi-R NEO 900A # 657 821 Serial #
The Issue: software error in the central control unit of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM go.Top
The Issue: The injector holder could potentially fall off together
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM go.Top
The Issue: The injector holder could potentially fall off together
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM go.Now
The Issue: The injector holder could potentially fall off together
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM go.All
The Issue: The injector holder could potentially fall off together
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM go.Up
The Issue: The injector holder could potentially fall off together
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM go.Up
The Issue: The injector holder could potentially fall off together
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.