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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- SunMed Holdings
- Product type
- Emergency Medical Organizer
- Model numbers
- Lot Code: Lot/Serial Number(s) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 15, 2025
Reported by FDA DEVICE
February 4, 2026
RecallRadar source check
February 11, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Locate the model number 7730ALS on the product.
- Check if your lot number matches any of the recalled codes: 0004312284, 0004314503, or 0004333110.
- 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.
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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.
Key Facts
- 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 Guide
Not sure what to do next? Our guide walks you through the process step by step.
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