SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Ver…

Recall date

December 15, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1114-2026

FDA classification

Class I

Brand / firm

SunMed Holdings, LLC

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.

Why it was recalled

Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA 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