Brand Name: Broselow Product Name: Broselow Pediatric Emergency… — Class I medical device recall Z-1115-2026
Ongoing recall by SunMed Holdings, LLC, reported 2026-02-04, distributed nationwide. Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
| Recall number | Z-1115-2026 |
|---|---|
| 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 | 2025-12-15 |
| Classified | 2026-01-28 |
| Reported by FDA | 2026-02-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, HK, SG |
| Quantity | 20,583 |
| Serial numbers | 0004325583, 0004329077, 0004329078, 0004329079, 0004331255, 0004333368, 0004335537, 0004338439, 0004340824, CASE-30889483588967, EACH-10889483588963 |
| Model numbers | 7700RE |
Product
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE 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
Reason for recall
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
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-1115-2026. 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.