← FDA ENFORCEMENT
Z-1116-2026Class I

SunMed Holdings, LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
SunMed Holdings, LLC
Product type
Device
Status
Ongoing
Report date
2026-02-04
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Firm state
MI
Product quantity
384
Initiated by
Voluntary: Firm initiated
Reason for recall

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

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

Code / lot info

Lot Code: Lot/Serial Number(s) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →