FDA Enforcement
Class I
Ongoing
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
Recall: Z-1117-2026
·
Reported February 4, 2026
Enforcement
- Recall Number
- Z-1117-2026
- Event ID
- 98208
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- SunMed Holdings, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 4, 2026
- Initiation Date
- December 15, 2025
- Classification Date
- January 28, 2026
- Address
- 2710 Northridge Dr Nw Ste A, N/A, Grand Rapids, MI, 49544-9112, United States
Description
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
Reason
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Code Info
Lot Code: Lot/Serial Number(s) 0004317699 0004333171 0004333593 UDI-DI Each-10889483589205 Case-30889483589209
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Quantity
89