Z-1116-2026Class I

Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS...

Name: Z-1116-2026 Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS...
Creator: SunMed Holdings, LLC
Published: 2025-12-15
License: https://open.fda.gov/license/

Salter Labs / initiated 2025-12-15 / Open, Classified / root cause: design

FDA source

SunMed Holdings, LLC began a recall of Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description... on 2025-12-15. FDA classified it as Class I and gives the reason as "Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1116-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-12-15
Posted: 2026-01-28
Recalling firm: Salter Labs
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
Product code: OKI Emergency Response Safety Kit
Reason for recall: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Root cause tag: design
FDA root cause: Device Design
Action: 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
Quantity in commerce: 384
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Product codes and lots: Lot Code: Lot/Serial Number(s) 0004312284 0004314503 0004333110 UDI-DI Each-10889483589151

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1116-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1114-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1115-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1116-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28
Z-1117-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-02-04	2026-01-28

Product code OKI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)