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 11381–11400 of 38,428 recalls
Recalled Item: Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX
The Issue: Power Wheelchairs with a LiNX Gyro component running
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX
The Issue: Power Wheelchairs with a LiNX Gyro component running
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with
The Issue: Power Wheelchairs with a LiNX Gyro component running
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruDi NAV Suction Instruments: 0-Degree
The Issue: Suction Instruments were incorrectly calibrated so they may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexor Check-Flo Introducer Ansel Modification Model Number:...
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexor Check-Flo Introducer Ansel Modification Model Number:...
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BV Endura with Software Release 2.3- A mobile
The Issue: Instructions for Use do not specify the maximum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Sonicision Battery Charger-intended to charge the Sonicision...
The Issue: Intermittent risk of electric shock to users if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Veradius Unity with Software Release 2.1- Amobile
The Issue: Instructions for Use do not specify the maximum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BV Pulsera with Software Release 2.3-A mobile
The Issue: Instructions for Use do not specify the maximum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stealthstation System w/ Stealthstation Cranial Software 3.1.1
The Issue: Cranial biopsy procedure software can enter a state
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing...
The Issue: Due to product label/labeling being altered from it's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PIVO Blood Collection Device 20G
The Issue: Incomplete sealing of blood collection device unit packages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iontoPATCH On-the-Go Patch Therapy
The Issue: The dosage information on the pouch is incorrect;
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNCHRON Systems Cholesterol (CHOL) Reagent
The Issue: Cholesterol Reagent may fail with Out of Calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amplatzer Steerable Delivery Sheath
The Issue: Instructions for use were updated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RAPID 20 E
The Issue: There is an error in the new version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Torosa Saline-Filled Testicular Prosthesis (Size Small)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stealth Autoguide Tracker
The Issue: A tracker that holds and guides neurosurgical surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Miami J Select Collar
The Issue: Instructions for use were updated to include additional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.