Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Numbe...
FDA Recall #Z-1116-2026 — Class I — December 15, 2025
Product Description
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
Reason for Recall
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Recalling Firm
SunMed Holdings, LLC — Grand Rapids, MI
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
384
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Code Information
Lot Code: Lot/Serial Number(s) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated