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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

AirLife Broselow Pediatric Emergency Rainbow Tape Recalled for Incorrect Data

Agency Publication Date: June 20, 2025
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Summary

SunMed Holdings, LLC has recalled 9,900 units of the AirLife brand Broselow Pediatric Emergency Rainbow Tape (2025 Edition). This pediatric emergency tool, used to determine medical doses based on a child's height and weight, contains incorrect printed information in the Red, Orange, and Grey zones. Because these zones are used to calculate critical life-saving interventions, using the incorrect values could lead to severe medical errors during an emergency. No injuries have been reported, and healthcare providers are advised to stop using the tapes and contact the manufacturer for replacement instructions.

Risk

Incorrect values on the tape can lead to children receiving excessive or insufficient shocks or medication doses. This poses a significant risk of cardiac arrest, heart damage, burns, and severe electrolyte imbalances.

What You Should Do

  1. This recall affects the AirLife brand Broselow Pediatric Emergency Rainbow Tape (REF 7700REA), specifically the 2025 Edition and Print Version 36-23446 Rev 2.
  2. Check the device label or packaging for Lot number 0004316661 and Unique Device Identifier (UDI) codes 10889483588970 (Each) or 30889483588974 (Case).
  3. Stop using the recalled device immediately to avoid potential dosing or treatment errors.
  4. Contact SunMed Holdings, LLC or your medical equipment distributor to arrange for a return, replacement, or correction of the tape.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

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

Affected Products

Product: Broselow Pediatric Emergency Rainbow Tape (2025 Edition)
Variants: AirLife brand, 36-23446 Rev 2 Print Version
Model / REF:
REF 7700REA
Lot Numbers:
0004316661
UDI:
10889483588970
30889483588974

Length- and weight-based reference tool specifically designed for pediatric emergency care.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96891
Status: Active
Manufacturer: SunMed Holdings, LLC
Sold By: AirLife; SunMed Holdings, LLC
Manufactured In: United States
Units Affected: 9900 eaches
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.