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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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.

The Hazard

The product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine, which can lead to serious medical complications.

Reported Incidents

No specific reported incidents have been documented regarding injuries or fatalities due to the dosing errors. The recall is classified as Class I, indicating a high level of risk.

What to Do

Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by the manufacturer and contact SunMed Holdings, LLC for further guidance.

Contact Information

For more information, contact SunMed Holdings, LLC or visit their website. Recall notifications will be sent via letter.

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

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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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