Class I — SunMed Holdings, LLC
| Recalling firm | SunMed Group Holdings, LLC dba AirLife |
|---|---|
| Registered facility | View this company's 7 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. |
| 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 |
| Quantity | 384 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore. |
| Initiated | 2025-12-15 |
| Classified | 2026-01-28 |
| Recall number | Z-1116-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — SunMed Holdings, LLC (Z-1116-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98208/
Alerts for SunMed Group Holdings, LLC dba AirLife
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.