Class II — King Systems Corp. dba Ambu, Inc.
| Recalling firm | KING SYSTEMS |
|---|---|
| Registered facility | KING SYSTEMS CORPORATION. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. |
| Product | KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430 |
| Quantity | 17925 units |
| Distribution | Nationwide |
| Initiated | 2024-09-26 |
| Classified | 2024-10-30 |
| Recall number | Z-0273-2025 |
| 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 II recall — King Systems Corp. dba Ambu, Inc. (Z-0273-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95451/
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