FDA Device recall Z-0270-2025
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway
- FDA Device
- Class II
- ongoing
- Published 2024-11-06
On 2024-11-06 the FDA classified a Class II recall of KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway by King Systems, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0270-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-26 |
| Published | 2024-11-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | King Systems |
| Distribution | US |
Product
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
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.
Identifiers
| code_info | UDI-DI: 00612649210162 (Shipper Label); 00612649210155 (Piece Label) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0270-2025%22
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