FDA Device recall Z-1116-2026
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable…
- FDA Device
- Class I
- ongoing
- Published 2026-02-04
On 2026-02-04 the FDA classified a Class I recall of Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable… by Sunmed Holdings, citing product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1116-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-12-15 |
| Published | 2026-02-04 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Sunmed Holdings |
| Distribution | US |
Product
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS 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.
Identifiers
| code_info | Lot Code: Lot/Serial Number(s) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1116-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.