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 501–520 of 38,428 recalls
Recalled Item: Ivenix Infusion System (IIS)
The Issue: Emphasizing instructions for LVP duration programming located in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK
The Issue: Firm received multiple complaints regarding tubing disconnecting from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with
The Issue: Issues identified: 1) Results vary by Instrument Platform;
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis MedStation ES
The Issue: Automated Dispensing Cabinets (ADC) received a Half Height
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Restore Clinician Programmer Application (CP App)
The Issue: Software issue where a Device Reset message displayed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe
The Issue: Reason for the voluntary recall is some products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product...
The Issue: Wire connected to the electrical box may shift
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product...
The Issue: Wire connected to the electrical box may shift
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AGFA Digital Radiography X- Ray system DR 800
The Issue: It is possible to exceed the maximum allowed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemosIL SynthAFax. Partial Thromboplastin Time Tests.
The Issue: Recalled lots were manufactured with double the amount
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hardware configuration of the BeneVision Central Monitoring System (CMS)
The Issue: When the Worstation of the BeneVision DMS has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intelerad InteleShare software
The Issue: Software intended to aid in diagnosing conditions, planning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Da Vinci 5 ASSY
The Issue: An error event following the release of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Molift Product Name: Molift 4-point sling bars (Accessory
The Issue: A customer experienced that during assembly and load
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Molift Product Name: Molift Mover 205 Model/Catalog Number:
The Issue: A customer experienced that during assembly and load
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Molift Product Name: Molift 2-point sling bars (Accessory
The Issue: A customer experienced that during assembly and load
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Molift Product Name: Molift Mover 300 Model/Catalog Numbers:
The Issue: A customer experienced that during assembly and load
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Pressio 2 ICP Monitoring System
The Issue: Customer complaints of Pressio monitor rebooting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sheathes3D Seamless Viral Barrier
The Issue: Vaginal/rectal ultrasound probe covers with a viral barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthofix NorthStar OCT Navigation Surgical Technique Guide
The Issue: The NorthStar OCT Navigation Surgical Technique Guide (STG)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.