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Home › FDA recalls › Brand Name: Broselow Product Name: Broselow Domestic Comple
CLASS I · SeriousFDA

SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer

📅 Dec 15, 2025 · 📍 Nationwide
Recalling company
SunMed Holdings, LLC
Product
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
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Classification
Class I – a reasonable probability that use will cause serious adverse health consequences or death
Recall date
Dec 15, 2025
Reported
Feb 4, 2026
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Status
Ongoing
Quantity
384
Lot / codes
Lot Code: Lot/Serial Number(s) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151
Company location
Grand Rapids, MI
Recall type
Voluntary: Firm initiated
Recall number
Z-1116-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1116-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.