# FDA recall Z-1904-2025

> **SunMed Holdings, LLC** · Class I · device recall initiated 2025-05-15.

## 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.

## Distribution

US distribution nationwide. International distribution to Canada.

## Key facts

- **Recall number:** Z-1904-2025
- **Recalling firm:** SunMed Holdings, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-15
- **Report date:** 2025-07-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grand Rapids, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1904-2025

## Citation

> AI Analytics. FDA recall Z-1904-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-1904-2025. Source: US FDA. Licensed CC0.

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