KING LTSD — Class II medical device recall Z-0276-2025
Ongoing recall by King Systems Corp. dba Ambu, Inc., reported 2024-11-06, distributed nationwide. Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for
| Recall number | Z-0276-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | King Systems Corp. dba Ambu, Inc., Noblesville, IN, United States |
| Recall initiated | 2024-09-26 |
| Classified | 2024-10-30 |
| Reported by FDA | 2024-11-06 |
| Distributed | Nationwide (US) |
| Quantity | 36,727 units |
| UPC / GTIN / UDI-DI | 00612649212746, 00612649212753 |
| Model numbers | KKLTSD4325 |
Product
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0276-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.