SunMed Holdings, LLC: Medical Device Recall in 2025 - (Recall #: Z-1904-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: May 15, 2025

Date Posted: July 2, 2025

Recall Number: Z-1904-2025

Event ID: 96891

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.

Status: Ongoing

Product Quantity: 9900 eaches

Code Information:

UDI-DI EA: 10889483588970 CS: 30889483588974 Lot 0004316661

Distribution Pattern:

US distribution nationwide. International distribution to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated