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
- Pediatric Emergency Tape
- 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
- 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
April 13, 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 Pediatric Emergency Rainbow Tape is a length- and weight-based reference tool designed for use in pediatric emergency care. It helps healthcare providers determine medication dosages based on a child's size.
Why This Is Dangerous
The tape has been found to contain potentially harmful dosing errors for critical pediatric medications, which can lead to serious health risks if administered incorrectly.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the tape immediately, as the incorrect dosages can pose serious health risks.
Practical Guidance
How to identify if yours is affected
- Check the model number on the product, which should read 7700REA.
- Review the lot codes listed in the recall announcement to see if yours is affected.
- Contact your healthcare provider for guidance if you are unsure.
Where to find product info
The model number and lot codes are typically printed on the packaging or the tape itself.
What timeline to expect
Expect a refund processing timeline of approximately 4-6 weeks once you follow the recall instructions.
If the manufacturer is unresponsive
- Contact the customer service hotline provided by SunMed Holdings.
- Document all correspondence and attempts to resolve the issue.
How to prevent similar issues
- Always verify product recalls through the FDA or manufacturer websites before using medical devices.
- Look for additional safety certifications when purchasing medical devices.
Documentation advice
Keep a record of your purchase receipt, any communication with the manufacturer, and photos of the product.
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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.
Key Facts
- Potential dosing errors for pediatric medications
- Stop use immediately
- Worldwide distribution including the US and Canada
- Follow recall instructions from manufacturer
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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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