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 4081–4100 of 38,428 recalls
Recalled Item: STREAMLINE BLOODLINE LONG VERSION
The Issue: Incomplete insertion of the patient connector of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Syringe Module Model 8110
The Issue: Due to affected devices that may have bent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to
The Issue: Incomplete insertion of the patient connector of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Tegaderm CHG
The Issue: Contamination with foreign substance matter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TxHA PEEK IBF/TxTiHA IBF System i. TxHA The
The Issue: Due to interfacing issues between the implant trial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soltive Premium SuperPulsed Laser - Intended for incision
The Issue: The term Bladder Stone was incorrectly translated in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soltive Pro SuperPulsed Laser Systems-Intended for incision
The Issue: The term Bladder Stone was incorrectly translated in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M
The Issue: This product labeling does not adequately provide warning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M
The Issue: This product labeling does not adequately provide warning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACSDuet Premium Sample Preparation System
The Issue: Sample preparation system with software may cause: 1)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Procedure Kit
The Issue: 7F sheath introducers labeled as 7.5F
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prelude Sheath Introducer 7.5F
The Issue: 7F sheath introducers labeled as 7.5F
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Seer Home System is an ambulatory electroencephalograph (EEG) system intended
The Issue: During CAPA investigations of sight production inconsistencies, it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of
The Issue: Product packaging process may result in an improper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of
The Issue: Product packaging process may result in an improper
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vios Monitoring System Bedside Monitor Model BSM2050
The Issue: Batteries may deplete over time while not in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERILIZABLE INTERNAL DEFIBRILLATION PADDLES STERILIZABLE INTERNAL...
The Issue: Due to customer complaints and out of box
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Panda iRES Warmer
The Issue: GE HealthCare has become aware that complete electrical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Giraffe Warmer
The Issue: GE HealthCare has become aware that complete electrical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Solo. Digital Mobile C-arm
The Issue: Ziehm Imaging, Inc., distributor, have been informed by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.