Recall Z-1114-2026 ยท OKI Emergency Response Safety Kit
SunMed Holdings, LLC
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
| Date | Jan 28, 2026 (initiated Dec 15, 2025) |
| Status | Open, Classified |
| Reason | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. |
| 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 identif |
| Quantity | 95300 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.