Broselow Pediatric Emergency Rainbow Tape — Class I medical device recall Z-1904-2025
Ongoing recall by SunMed Holdings, LLC, reported 2025-07-02, distributed nationwide. The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the
| Recall number | Z-1904-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SunMed Holdings, LLC, Grand Rapids, MI, United States |
| Recall initiated | 2025-05-15 |
| Classified | 2025-06-20 |
| Reported by FDA | 2025-07-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 9,900 eaches |
| UPC / GTIN / UDI-DI | 10889483588970, 30889483588974 |
| Lot numbers | 0004316661 |
| Model numbers | 7700REA |
Product
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife brand, 2025 Edition, and 36-23446 Rev 2 Print Version The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care.
Reason for recall
The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in the Red zone, Orange zone, and Grey zone. Using the incorrect values in the Red zone could lead to shocking a patient with an excessive dose of joules, causing significant harm including burns, heart damage, and cardiac arrest. Incorrect values in the Orange zone could lead to overdosing the patient with sodium bicarbonate and cause metabolic alkalosis, electrolyte imbalances, tissue damage, and worsen respiratory status. Incorrect information in the Grey may lead to underdosing the patient with sodium bicarbonate and may cause reduced myocardial contractility, decreased response to vasopressors, and increased risk of dysrhythmia.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1904-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.