FDA Medical devices recall ·
Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1114-2026
- Date
- (initiated December 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
- 95300
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
Why was it recalled?
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
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
Lot Code: Lot/Serial Number(s) 0004306540 0004316209 0004328895 0004329080 0004330876 0004331254 0004332994 0004338228 0004338229 0004338230 0004339717 UDI-DI Each-10889483588970 Case-30889483588974
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
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-1114-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.