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BROSELOW recallZ-1117-2026 · SunMed Holdings, LLC · initiated Dec 15, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from SunMed Holdings, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

FDA root cause category: Device Design

What the company is doing

AirLife issued an URGENT: MEDICAL DEVICE RECALL NOTICE to its consignees on 12/15/2025 via email and US mail. The notice explained the issue, potential risk to the patient, and requested the following: "Customer immediate actions: Please take the following actions immediately: 1. Stop using the affected tapes o Immediately discontinue use of all AirLife Broselow Rainbow Tapes identified as 2025 Edition, 36-23446 Rev 3 Print Version. 2. Identify and segregate affected product o Examine your inventory and clinical areas for affected Broselow Rainbow Tapes (see Image B for identifying characteristics). o Remove all affected tapes from clinical service. o Segregate or quarantine the affected tapes to prevent further use. 3. Follow disposition instructions o Follow the instructions provided in the accompanying communication regarding discarding/destruction of the affected tapes. o Do not redistribute or place any affected tapes back into service. 4. Notify your internal users o Ensure that all clinicians and healthcare professionals within your organization who may use the Broselow Rainbow Tape are informed of this recall/field removal and understand that the affected Rev 3 tapes must not be used. 5. Notify downstream customers (if applicable) o If you have further distributed the affected tapes, please identify your customers/consignees and notify them of this recall/field removal promptly. o Your notification may be enhanced by including a copy of this letter. o If you have impacted product on hand, do not ship it; instead, hold it for discarding/destruction as instructed. 6. Complete and return the Response Form o Please complete and return the attached Response Form via e-mail to [email protected] as soon as possible. Please complete and return Attachment B if you have affected product for discarding/destruction. This allows us to document your receipt of this recall notice and the status of affected product at

Recall details

Recall number
Z-1117-2026
Status
Open, Classified
Initiated by the company
Dec 15, 2025
Posted by the FDA
Jan 28, 2026
Recalling firm
SunMed Holdings, LLC
Quantity
89
Product code
OKI
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.

Product 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

Code information (models, lots, serial numbers)

Lot Code: Lot/Serial Number(s) 0004317699 0004333171 0004333593 UDI-DI Each-10889483589205 Case-30889483589209

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98208).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page