HIGH

SunMed Recalls Broselow Pediatric Emergency Tape Over Dosing Errors

SunMed Holdings recalled 95,300 units of Broselow Pediatric Emergency Rainbow Tape on December 15, 2025. The tape contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. Patients and healthcare providers must stop using the product immediately.

Quick Facts at a Glance

Recall Date
December 15, 2025
Hazard Level
HIGH
Brand
SunMed Holdings
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
CHILDREN, GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact SunMed Holdings, LLC or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled product is the Broselow Pediatric Emergency Rainbow Tape, model number 7700REA. It was distributed worldwide, including the United States, Canada, Hong Kong, and Singapore.

The Hazard

The Broselow Tape has been found to contain dosing errors for critical medications used in pediatric emergency care. These errors pose a high risk of adverse effects for patients.

What to Do

Patients and healthcare providers should stop using the Broselow Tape immediately. Contact SunMed Holdings or your healthcare provider for further instructions and to follow the recall process.

Contact Information

For more information, contact SunMed Holdings, LLC at their customer service line or visit the official recall page provided by the FDA.

Key Facts

  • 95,300 units recalled
  • Potential dosing errors for pediatric medications
  • Stop use immediately
  • Worldwide distribution including the US and Canada
  • Follow recall instructions from manufacturer

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
CHILDRENGENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot Code: Lot/Serial Number(s) 0004306540 0004316209 0004328895 0004329080 0004330876 0004331254 0004332994 0004338228 0004338229 0004338230 0004339717 UDI-DI Each-10889483588970 Case-30889483588974
Affected States
ALL
Report Date
February 4, 2026
Recall Status
ACTIVE

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