FDA recall, , High risk
Broselow Pediatric Emergency Tape and Organizers
Broselow Pediatric Emergency Tape and Organizers contain potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Summary by Recall Canary from the FDA notice
What happened
SunMed Holdings, LLC of Grand Rapids, Michigan recalled Broselow products containing potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. The recall began December 15, 2025 and was added to the FDA's Enforcement Report on January 28, 2026, with distribution nationwide and in Canada, Hong Kong, and Singapore. The products include Broselow Filled Broselow Organizer, Broselow Domestic Complete ALS Organizer, and Broselow Pediatric Emergency Rainbow Tape.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match your product and all the details in one listed combination.
A UDI-DI is the device identifier printed with the barcode on the device label.
Broselow Pediatric Emergency Rainbow Tape
- UDI-DI
- 0004325583
- 0004329077
- 0004329078
- 0004329079
- 0004331255
- 0004333368
- 0004335537
- 0004338439
- 0004340824
- 10889483588963
- 30889483588967
- Model/Catalog number
- 7700RE
- UDI-DI
- 0004306540
- 0004316209
- 0004328895
- 0004329080
- 0004330876
- 0004331254
- 0004332994
- 0004338228
- 0004338229
- 0004338230
- 0004339717
- 10889483588970
- 30889483588974
- Model/Catalog number
- 7700REA
Broselow" Filled Broselow Organizer
- UDI-DI
- 0004317699
- 0004333171
- 0004333593
- 10889483589205
- 30889483589209
- Model/Catalog number
- 7730IALS
Broselow Domestic Complete ALS Organizer
- UDI-DI
- 0004312284
- 0004314503
- 0004333110
- 10889483589151
- Model/Catalog number
- 7730ALS
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
- Company
- SunMed Holdings, LLCGrand Rapids, Michigan
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98208
- Recall numbers
- Z-1114-2026 to Z-1117-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
