FDA DevicesClass I
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/C...
Published: February 4, 2026Recall ID: Z-1117-2026Category: devicesCountry: US
Reason for Recall / Hazard
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Product Description & Identification
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS 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
Affected Products
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS 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
Additional Source Details
| Field | Value |
|---|---|
| City | Grand Rapids |
| State | MI |
| Event id | 98208 |
| Address 1 | 2710 Northridge Dr Nw Ste A |
| Address 2 | N/A |
| Code info | Lot Code: Lot/Serial Number(s) 0004317699 0004333171 0004333593 UDI-DI Each-10889483589205 Case-30889483589209 |
| Postal code | 49544-9112 |
| Report date | 20260204 |
| Product type | Devices |
| Product quantity | 89 |
| Reason for recall | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251215 |
| Initial firm notification | Letter |
| Center classification date | 20260128 |
Overview
- Recalling FirmSunMed Holdings, LLC
- StatusOngoing
- Risk LevelClass I
- DistributionWorldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.