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 32781–32800 of 38,428 recalls
Recalled Item: WaterLase iPlus Dental Laser System
The Issue: Biolase is recalling the WaterLase iPlus Dental Laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P
The Issue: A small number of sealed foil pouches containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope...
The Issue: Aspiration needles used in combination with Ultrasound Gastroscopes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW
The Issue: Two lots of screws were commingled. Screws with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Suture Set
The Issue: Some of the sterile kits may have incomplete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safety Laceration Kit
The Issue: Some of the sterile kits may have incomplete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Max Barrier Kit
The Issue: Some of the sterile kits may have incomplete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laceration/Suture Removal
The Issue: Some of the sterile kits may have incomplete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laceration Trays
The Issue: Some of the sterile kits may have incomplete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laceration Kit: W/Needles
The Issue: Some of the sterile kits may have incomplete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Port-A-Cath Tray
The Issue: Some of the sterile kits may have incomplete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Medi-Pak
The Issue: Some of the sterile kits may have incomplete
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prosound F75 or F75 The Hitachi Aloka Medical
The Issue: Loosened monitor arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+ Infusion System with Hospira MedNet List 20792-04-25
The Issue: Plum A+ infusion system pole clamp assemblies were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. For use
The Issue: for misalignment of the Z-stage scale. Using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE
The Issue: Failure of the CO2 detector in Single-width Airway
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tritium Sternal Plate System
The Issue: Lack of Sterility Assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo Scientific VersaTREK REDOX 1
The Issue: Bottles did not provide positive signals within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra¿ LED Battery Charger
The Issue: LED battery chargers may prematurely fail and will
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IS4000 da Vinci Xi - Endoscope accessory
The Issue: In some procedures when using the endoscope in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.