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 6901–6920 of 38,428 recalls
Recalled Item: ARTIS icono (ceiling configuration)
The Issue: hardware issue for ARTIS icono ceiling system:
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOFIRE Blood Culture Identification 2 (BCID2) Panel
The Issue: Routine quality control testing of affected blood culture
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray TORCH . HTFA-ASY-0104 is the BIOFIRE TORCH Base
The Issue: Due to an increased risk of degradation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCF-H190DL
The Issue: Specific devices may have an improperly repaired light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
The Issue: Specific devices may have an improperly repaired light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitality Polyaxial Screw
The Issue: Spinal fixation system 7.5mmx 50mm screws are packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray
The Issue: The component tracheostomy brush has a sharp edge
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Nursing Skills kit
The Issue: The component tracheostomy brush has a sharp edge
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Nurse Kit
The Issue: The component tracheostomy brush has a sharp edge
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCF-H190L
The Issue: Specific devices may have an improperly repaired light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GIF-H190
The Issue: Specific devices may have an improperly repaired light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GIF-HQ190
The Issue: Specific devices may have an improperly repaired light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093
The Issue: Produced with unintended open slits on the side
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVANOS BALLARD Closed Suction System for Adults
The Issue: Certain lots of BALLARD Closed Suction System for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novum IQ Syringe infusion system
The Issue: Baxter is issuing an Urgent Medical Device Correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unity CR Femur Right
The Issue: for Unity CR Inserts Right size 6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unity Total Knee System
The Issue: for Unity CR Inserts Right size 6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device
The Issue: The Mo.Ma Ultra device manifold is labelled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device
The Issue: The Mo.Ma Ultra device manifold is labelled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device
The Issue: The Mo.Ma Ultra device manifold is labelled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.