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Home › FDA recalls › Brand Name: Broselow Product Name: Broselow Pediatric Emerg
CLASS I · SeriousFDA

SunMed Holdings, LLC recalls Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape

📅 Dec 15, 2025 · 📍 Nationwide
Recalling company
SunMed Holdings, LLC
Product
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE 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
20583
Lot / codes
Lot Code: Lot/Serial Number(s) 0004325583 0004329077 0004329078 0004329079 0004331255 0004333368 0004335537 0004338439 0004340824 UDI-DI Each-10889483588963 Case-30889483588967
Company location
Grand Rapids, MI
Recall type
Voluntary: Firm initiated
Recall number
Z-1115-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1115-2026 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.