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) 0004325583 0004329077 0004329078 0004329079 0004331255 0004333368 0004335537 0004338439 0004340824 UDI-DI Each-10889483588963 Case-30889483588967
- 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 reference tool used in pediatric emergency care to provide weight-based medication dosages. It is crucial for healthcare providers to ensure accurate dosing for children in emergency situations.
Why This Is Dangerous
The recalled tape contains potentially harmful dosing errors for critical medications used in emergencies, which can result in incorrect dosages being administered to patients, especially children.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers and emergency care settings, as they must immediately halt use of the tape, which could lead to delays in care.
Practical Guidance
How to identify if yours is affected
- Check the model number on the tape, which is 7700RE.
- Verify the lot codes against the recalled lot codes listed in the recall notification.
- Confirm that you purchased the tape from an authorized retailer.
Where to find product info
The model number and lot codes can be found printed on the packaging of the tape.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks after submitting your request.
If the manufacturer is unresponsive
- Contact SunMed Holdings directly for follow-up inquiries.
- File a complaint with the FDA if no response is received.
How to prevent similar issues
- Always verify the latest safety information for medical devices before use.
- Consider using electronic dosing calculators that are regularly updated for accuracy.
- Stay informed about product recalls in the medical device category.
Documentation advice
Keep records of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.
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Product Details
The Broselow Pediatric Emergency Rainbow Tape, Model 7700RE, is a length- and weight-based reference tool for pediatric emergency care. It was distributed worldwide, including the US, Canada, Hong Kong, and Singapore.
Key Facts
- Model: Broselow Pediatric Emergency Rainbow Tape
- Quantity recalled: 20,583 units
- Hazard: Dosing errors for Vecuronium, Flumazenil, and Ketamine
- Recall date: December 15, 2025
- Stop using the tape immediately
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Safety Guide
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