Changeflow GovPing Healthcare SunMed Broselow Tape Recall - Class I
Urgent Enforcement Removed Final

SunMed Broselow Tape Recall - Class I

Favicon for changeflow.com FDA: Device Recalls Class I
Filed February 4th, 2026
Detected March 27th, 2026
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Summary

The FDA has issued a Class I recall for SunMed Holdings' Broselow Pediatric Emergency Rainbow Tape due to potentially harmful dosing errors for specific medications. The recall affects worldwide distribution, including the US, Canada, Hong Kong, and Singapore.

What changed

The FDA has classified a recall for SunMed Holdings' Broselow Pediatric Emergency Rainbow Tape as Class I, indicating a serious health risk. The recall stems from identified dosing errors for Vecuronium, Flumazenil, and Ketamine when using the tape, which is designed to assist in pediatric emergency dosing.

Healthcare providers and facilities that have distributed or used this product must immediately stop using it and quarantine any remaining stock. The FDA urges prompt action to prevent potential patient harm due to incorrect medication dosages. The recall is ongoing and affects distribution worldwide, including the United States.

What to do next

  1. Stop using the Broselow Pediatric Emergency Rainbow Tape.
  2. Quarantine any remaining product stock.
  3. Notify relevant parties about the recall.

Source document (simplified)

SunMed Holdings, LLC

Device Recalls (Class I)

← All Device Recalls (Class I) Class I Z-1115-2026 · 20260204 · Ongoing

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- an...

Reason for Recall

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

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.

Source: openFDA Enforcement API

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
February 4th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Z-1115-2026

Who this affects

Applies to
Drug manufacturers Healthcare providers Medical device makers
Industry sector
3254 Pharmaceutical Manufacturing 3345 Medical Device Manufacturing 6211 Healthcare Providers
Activity scope
Medical Device Recalls Drug Dosing
Geographic scope
United States US

Taxonomy

Primary area
Product Safety
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Medical Devices Pharmaceuticals

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