FDA Medical devices recall ·
Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife) recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1904-2025
- Date
- (initiated May 15, 2025)
- Company / brand
- SunMed Holdings, LLC
2710 Northridge Dr Nw Ste A, Grand Rapids, MI, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 9900 eaches
- Hazard tags
- Burn Electrical shock
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI EA: 10889483588970 CS: 30889483588974 Lot 0004316661
Distribution
US distribution nationwide. International distribution to Canada.
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1904-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.