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
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 Care Organizer
- Model numbers
- Lot Code: Lot/Serial Number(s) 0004317699 0004333171 0004333593 UDI-DI Each-10889483589205 Case-30889483589209
- 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 FILLED BROSELOW ORGANIZER is designed for pediatric emergency care, providing length- and weight-based medication dosing references. Medical professionals rely on this tool for accurate medication administration during emergencies.
Why This Is Dangerous
The dosing errors for Vecuronium, Flumazenil, and Ketamine can lead to serious health risks for pediatric patients. Accurate dosing is critical in emergency situations, making this recall particularly urgent.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall requires immediate action from healthcare providers, impacting their ability to deliver safe and effective care to pediatric patients.
Practical Guidance
How to identify if yours is affected
- Locate the model number 7730IALS on your product packaging.
- Ensure you are aware of the recall date and stop using the product.
Where to find product info
Model numbers and lot codes can usually be found on the product label or packaging.
What timeline to expect
Refund processing typically takes 4-6 weeks after the product is returned.
If the manufacturer is unresponsive
- Document your communication attempts with the company.
- Follow up via email or phone if you do not receive a response within a week.
- Consider filing a complaint with the CPSC if issues persist.
How to prevent similar issues
- Always verify the accuracy of medical devices before use.
- Look for FDA recalls or alerts before using medical products.
- Consult with a healthcare provider for alternatives when in doubt.
Documentation advice
Keep records of your purchase receipt, any correspondence with the manufacturer, and photos of the product for documentation.
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Product Details
The recalled product is the BROSELOW FILLED BROSELOW ORGANIZER, model number 7730IALS. It has worldwide distribution, including the U.S., Canada, Hong Kong, and Singapore.
Key Facts
- Recall date: December 15, 2025
- Product contains harmful dosing errors
- Distributed worldwide including the U.S.
- Immediate action required from healthcare providers
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Safety Guide
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