Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer ... recall (SunMed Holdings, LLC)
Medical deviceClass IOngoing
Summary: SunMed Holdings, LLC is recalling 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.
What is being recalled
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
Why
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
How to tell if yours is affected
Lot Code: Lot/Serial Number(s) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1116-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | December 15, 2025 |
| Reported | February 4, 2026 |
| Company | SunMed Holdings, LLC |
| Company location | Grand Rapids, MI, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 384 |
More recalls from SunMed Holdings, LLC · all medical device recalls · recalls from December 2025