Class IIOngoingZ-1342-2026
Alphatec Spine, Inc. recalls ATEC Lateral Navigation Disc Prep Instruments LIF NAV
Due a design issue where the navigated array connection geometry is incorrect.
Alphatec Spine, Inc.CAFeb 18, 2026
Recalls: Device Design
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 157–168 of 621 recalls
Class IIOngoingZ-1223-2026
Olympus Corporation Of The Americas recalls Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use E…
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Olympus Corporation of…PAFeb 11, 2026
Class IIOngoingZ-1222-2026
Olympus Corporation Of The Americas recalls Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electros…
A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
Olympus Corporation of…PAFeb 11, 2026
Class IOngoingZ-1117-2026
SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog…
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
SunMed Holdings, LLCMIFeb 4, 2026
Class IOngoingZ-1116-2026
SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Cat…
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
SunMed Holdings, LLCMIFeb 4, 2026
Class IOngoingZ-1115-2026
SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Ca…
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
SunMed Holdings, LLCMIFeb 4, 2026
Class IOngoingZ-1114-2026
SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Ca…
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
SunMed Holdings, LLCMIFeb 4, 2026
Class IIOngoingZ-1155-2026
Edan Diagnostics recalls Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Prod…
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan DiagnosticsCAJan 28, 2026
Class IIOngoingZ-1154-2026
Edan Diagnostics recalls Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan DiagnosticsCAJan 28, 2026
Class IIOngoingZ-1153-2026
Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product…
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan DiagnosticsCAJan 28, 2026
Class IIOngoingZ-1152-2026
Edan Diagnostics recalls Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product…
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan DiagnosticsCAJan 28, 2026
Class IIOngoingZ-1151-2026
Edan Diagnostics recalls Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
Edan DiagnosticsCAJan 28, 2026