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 7141–7160 of 38,428 recalls
Recalled Item: Monoject" 60 mL Syringe Luer-Lock Tip Soft Pack
The Issue: Demonstrated recognition and compatibility issues with syringe infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
The Issue: Demonstrated recognition and compatibility issues with syringe infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject" 6 mL Syringe Luer-Lock Tip Soft Pack
The Issue: Demonstrated recognition and compatibility issues with syringe infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject" 35 mL Syringe Luer-Lock Tip Soft Pack
The Issue: Demonstrated recognition and compatibility issues with syringe infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists
The Issue: Eye syncing issues causing the device to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeadCare II Blood Lead Test Kit-For in vitro diagnostic use
The Issue: During an internal audit a small percentage (<10%)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System
The Issue: Device packaged inside an incorrect outer box; displaying
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Express Dry Seal Chest Drains (Express): 4000-100N DRAIN
The Issue: Instructions for Use (IFU) for the Atrium Ocean,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ocean Water Seal Chest Drains (Ocean): Products Product
The Issue: Instructions for Use (IFU) for the Atrium Ocean,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN
The Issue: Instructions for Use (IFU) for the Atrium Ocean,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IBA Proton Therapy System - PROTEUS 235. PTS-11 versions
The Issue: The patient positioning system can perform motions in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure
The Issue: risk of reporting erroneous creatinine patient results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood
The Issue: risk of reporting erroneous creatinine patient results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal Head and Neck procedure kit
The Issue: DeRoyal is recalling certain lots of surgical procedure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris PCA Module 8120
The Issue: Alaris PCA Module 8120, Patient Controlled Analgesia infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris Syringe Module
The Issue: Alaris PCA Module 8120, Patient Controlled Analgesia infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris PCU
The Issue: Alaris PCA Module 8120, Patient Controlled Analgesia infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Senhance Surgical System
The Issue: Asensus Surgical has identified a malfunction that has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate
The Issue: One lot of Tournier Perform Reversed Lateralized Baseplates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA III Video System Center Model Number CV-190. Intended
The Issue: Certain serial numbers of the CV-190 do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.