FDA-Device2026-02-04Class IMISBRANDING
SunMed Broselow Pediatric Emergency Tape recalled for medication dosing errors
What this means
The Broselow Tape, a tool used in pediatric emergencies to calculate medication doses based on a child's length and weight, contains incorrect dosing information for three medications: Vecuronium, Flumazenil, and Ketamine. These errors could lead to wrong doses being given during emergency care. The FDA has classified this as a Class I recall, the most serious category.
- Stop using the affected Broselow Tape immediately if you have one in your facility
- Check if your tape's lot number matches the list provided by the FDA
- Contact SunMed Holdings or your medical supplier for a replacement or corrected version
- Notify your clinical staff and emergency team about this recall
The agency's original wording
Hazard
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Intended for
Children (under 18 years)
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Affected count
95300
Manufactured in
2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1114-2026Want us to check the next one for you?
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