Pediatric ALS organizers recalled over potentially harmful drug dosing errors
SunMed Holdings is recalling 384 units of the Broselow Domestic Complete ALS Organizer because the product contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Undeclared wheat. The notice does not report any illnesses, injuries or deaths. The notice states: "Undeclared wheat."
Plain-English summary
The Broselow Domestic Complete ALS Organizer, model/catalog number 7730ALS, is being recalled by SunMed Holdings, LLC. The record describes the Broselow Tape as a length- and weight-based reference tool.
The reason given in the enforcement record is that the product contains potentially harmful dosing errors for Vecuronium, Flumazenil and Ketamine.
The record lists 384 units, with lot or serial numbers and UDI-DI codes recorded in the enforcement record. Distribution was worldwide, covering the United States nationwide and Canada, Hong Kong and Singapore. The FDA has classified the action as Class I, its most serious category.
Clinicians should stop using the affected tool for dosing and follow SunMed's instructions.
The recalled product
- Product
- SOMA KITCHEN NATURAL ASAFOETIDA Net Wt. 4 oz (0.25 lb) Product of India Manufactured for and Imported by: Bharat Bazar, Fremont, CA 94539 Use by : JULY-2027 Lot : NATL/ASFTP/G/24 (BB/ASFTP/G/24) UPC : 4 973993 173586 Ingredients :- Natural Hing
- Manufacturer
- BHARAT BAZAR
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Use by : JULY-2027 Lot : NATL/ASFTP/G/24 (BB/ASFTP/G/24) UPC : 4 973993 173586
Distribution
Distributed in 1 state:
Related recalls
Same hazard · dosing error
See all →- SevereMajor Pharmaceuticals Recalls Levothyroxine Sodium Tablets Over Subpotency
FDA (Drugs) · 2026-07-29
- SevereLevothyroxine Sodium Tablets Recalled for Subpotency
FDA (Drugs) · 2026-07-29
- HighPhothera 200 phototherapy calibration certificates had outputs reversed
FDA (Devices) · 2026-06-10
- HighMedline eye trays contain insulin syringes labeled as tuberculin syringes
FDA (Devices) · 2026-06-03
- CriticalPediatric emergency tapes recalled over potentially harmful drug dosing errors
FDA (Devices) · 2026-02-04
Similar recalls
- CriticalFilled Broselow organizers recalled over potentially harmful dosing errors
FDA (Devices) · 2026-02-04
- CriticalPediatric emergency tapes recalled over potentially harmful drug dosing errors
FDA (Devices) · 2026-02-04
- CriticalBroselow Rainbow Tape 7700RE recalled over potentially harmful dosing errors
FDA (Devices) · 2026-02-04
- SevereBroselow Pediatric Emergency Rainbow Tape recalled for incorrect dosing values
FDA (Devices) · 2025-07-02
- ModerateApothecary Shoppe Recalls Phentolamine Vials Due to Sterility Concerns
FDA (Drugs) · 2015-08-12
- LowA-S Medication Solutions Recalls Acetaminophen and Codeine Tablets Due to Labeling Error
FDA (Drugs) · 2016-05-11