Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA 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
FDA Recall Z-1114-2026 · Posted 2026-01-28
Recalling FirmSunMed Holdings, LLC
Recall StatusOpen, Classified
Product CodeOKI
Date Initiated2025-12-15
Product Quantity95300
Reason for Recall
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Firm 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
Root Cause
Device Design
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.