FDA-Device2026-02-04Class IMISBRANDING
Broselow Domestic Complete ALS Organizer recalled for incorrect medication dosing
FALSE CLAIMSNationwide distribution
Stop using Broselow ALS Organizer model 7730ALS
The Broselow Tape, a tool used in pediatric emergency care to determine correct medication doses based on a child's length and weight, contains dosing errors for three medications: Vecuronium, Flumazenil, and Ketamine. These errors could lead to incorrect doses being given during emergency treatment.
- Stop using Broselow Domestic Complete ALS Organizer model 7730ALS immediately
- Check if your facility received lot numbers 0004312284, 0004314503, or 0004333110
- Contact SunMed Holdings or your device supplier for instructions on replacement or verification
- Review any recent uses of this tool to ensure correct doses were administered
Hazard
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Affected count
384
Manufactured in
2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1116-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief