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 19361–19380 of 38,428 recalls
Recalled Item: STEPHANIX D2RS Digital Dynamic Remote...
The Issue: The firm has detected a potential risk using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ascom Telligence Nurse Call System
The Issue: There is an issue that could cause the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RadPRO(R) Mobile 40kW Digital X-Ray System - Model: SM-40HF-B-D-C Product
The Issue: There is a potential for the RadPRO Mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SORIN Heater-Cooler System 3T 120V~/60Hz Description of product:
The Issue: The firm has become aware that due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS NT-proBNP Reagent
The Issue: The firm is extending their previous July 2018
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Anti-HBe Reagent Pack
The Issue: The firm is extending their previous July 2018
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quantikine¿ IVD¿ ELISA
The Issue: The Human sTfR Quantikine IVD ELISA Kit, catalog
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS HBeAg Reagent
The Issue: The firm is extending their previous July 2018
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ultra2 Genesys Variants Analyzer
The Issue: lack of 510K
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genesys 2 Reagent
The Issue: lack of 510K
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genesys Analytical Column
The Issue: lack of 510K
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genesys Diluent Reagent
The Issue: lack of 510K
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genesys 1 Reagent
The Issue: lack of 510K
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The SQ-RX Pulse Generator a component of the Subcutaneous Implantable
The Issue: Experienced accelerated battery depletion and a shortened replacement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Protexis Neoprene Surgical Glove
The Issue: Labeling issue in that the breakthrough (i.e., permeation)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Protexis Neoprene Surgical Glove
The Issue: Labeling issue in that the breakthrough (i.e., permeation)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Protexis Neoprene Surgical Glove
The Issue: Labeling issue in that the breakthrough (i.e., permeation)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FoundationOne CDx Test Results
The Issue: An incorrect test result for a single analyte
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Protexis Neoprene Surgical Glove
The Issue: Labeling issue in that the breakthrough (i.e., permeation)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen¿ Complete Knee Solution Femoral Augment Block Distal only
The Issue: Screw is missing from the package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.