HIGH

Broselow Recall Due to Dangerous Dosing Errors in ALS Organizer

Broselow recalled 384 units of their Domestic Complete ALS Organizer on December 15, 2025, due to harmful dosing errors. The recalled product affects dosages for Vecuronium, Flumazenil, and Ketamine. Healthcare providers and patients must stop using the device 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
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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About This Product

The Broselow Domestic Complete ALS Organizer is a pediatric emergency care tool used to assist in medication dosing based on a child's weight and length. Healthcare providers commonly use this device during emergency situations to ensure accurate dosing for critical medications.

Why This Is Dangerous

The device contains potentially harmful dosing errors for key medications, which can lead to incorrect dosing and serious health complications in pediatric patients. This poses a significant risk during emergencies where precise dosing is critical.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

This recall poses a serious risk for healthcare providers relying on accurate dosing in emergency situations, potentially endangering patient safety.

Practical Guidance

How to identify if yours is affected

  1. Locate the model number 7730ALS on the product.
  2. Check if your lot number matches any of the recalled codes: 0004312284, 0004314503, or 0004333110.
  3. Ensure the product is not used in any medical situations until verified.

Where to find product info

The model number and lot codes are usually found on the packaging or the product label.

What timeline to expect

Expect a refund processing time of approximately 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Contact SunMed Holdings directly for assistance.
  • Follow up via email or phone if there is no response after a week.

How to prevent similar issues

  • Always verify product recalls through official health sources such as the FDA.
  • Look for safety certifications when purchasing medical devices.
  • Stay informed about potential hazards associated with medical equipment.

Documentation advice

Keep all correspondence regarding the recall, including notification letters and any return shipping receipts.

Product Details

The recalled product is the Broselow Domestic Complete ALS Organizer, Model/Catalog Number 7730ALS. It was distributed worldwide, including the US, Canada, Hong Kong, and Singapore.

Key Facts

  • 384 units recalled
  • Dosing errors for Vecuronium, Flumazenil, and Ketamine
  • Class I recall indicates high risk
  • Stop using the product immediately
  • Contact manufacturer for further instructions

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
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot Code: Lot/Serial Number(s) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151
Affected States
ALL
Report Date
February 4, 2026
Recall Status
ACTIVE

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