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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Diagnostic Equipment

Broselow Pediatric Emergency Rainbow Tapes Recalled for Dosing Errors

Agency Publication Date: January 28, 2026
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Summary

SunMed Holdings, LLC is recalling 116,356 units of Broselow Pediatric Emergency Rainbow Tapes and ALS Organizer kits because they contain potentially harmful dosing errors for the medications Vecuronium, Flumazenil, and Ketamine. The Broselow Tape is a critical reference tool used by healthcare providers during pediatric emergencies to determine medication dosages based on a child's length and weight. Incorrect dosage information on these tapes could lead to significant medication errors during life-saving procedures.

Risk

The product contains incorrect dosing instructions for three specific medications, which can result in patients receiving too much or too little of a drug during a medical emergency. This poses a critical risk of patient harm, including ineffective treatment or toxicity during emergency pediatric care.

What You Should Do

  1. Identify your product by checking for model numbers 7700REA, 7700RE, 7730ALS, or 7730IALS on the device label or packaging.
  2. Check the lot number or UDI-DI printed on your product or its original carton. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled product immediately to avoid medication dosing errors.
  4. Contact SunMed Holdings, LLC or your distributor to arrange for a return, replacement, or correction of the affected emergency tapes and organizers.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Broselow Pediatric Emergency Rainbow Tape
Model / REF:
7700REA
Lot Numbers:
0004306540
0004316209
0004328895
0004329080
0004330876
0004331254
0004332994
0004338228
0004338229
0004338230
0004339717
UDI:
10889483588970
30889483588974

The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.

Product: Broselow Pediatric Emergency Rainbow Tape
Model / REF:
7700RE
Lot Numbers:
0004325583
0004329077
0004329078
0004329079
0004331255
0004333368
0004335537
0004338439
0004340824
UDI:
10889483588963
30889483588967

The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.

Product: Broselow Domestic Complete ALS Organizer
Model / REF:
7730ALS
Lot Numbers:
0004312284
0004314503
0004333110
UDI:
10889483589151

The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.

Product: BROSELOW FILLED BROSELOW ORGANIZER
Model / REF:
7730IALS
Lot Numbers:
0004317699
0004333171
0004333593
UDI:
10889483589205
30889483589209

The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98208
Status: Active
Manufacturer: SunMed Holdings, LLC
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 4 products (95300; 20583; 384; 89)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.