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KING LTS-D Kit KLTSD431Recalls & reported problems

King Systems Corporation · AMBU / KING LTSD, SIZE 1,W/SUCTION PORT, NON-STERILE KIT · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Sep 26, 2024Open, Classified

    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.

    Z-0274-2025 · Root cause: No Marketing Application · FDA record ↗

Other AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.