Z-0275-2025Class II

KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to...

Name: Z-0275-2025 KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to...
Creator: King Systems Corp. dba Ambu, Inc.
Published: 2024-09-26
License: https://open.fda.gov/license/

King Systems Corporation. / initiated 2024-09-26 / Open, Classified

FDA source

King Systems Corp. dba Ambu, Inc. began a recall of KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432 on 2024-09-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0275-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-26
Posted: 2024-10-30
Recalling firm: King Systems Corporation.
Product: KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432
Product code: CAE Airway, Oropharyngeal, Anesthesiology
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.
FDA root cause: No Marketing Application
Action: King Systems issued Urgent Field Safety Notice on 9/26/624 via email/Certified Mail. Letter states reason for recall, health risk and action to take: You must discontinue use and dispose of King LTS-D" Disposable Laryngeal Tube pediatric sizes and identify alternative devices for appropriate airway management. Within one month of receipt of this notice, please provide return response for this Field Safety Notice. This Notice needs to be passed on to all those who might concern within your organization where the devices could have been transferred. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness of this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Patient safety remains our highest priority. If you have additional questions regarding this information, please contact your local Ambu-King Systems sales representative. Should you have additional questions, please do not hesitate to contact Tammy Feyerherm at [email protected].
Quantity in commerce: 44755 units
Distribution: Nationwide
Product codes and lots: UD-DI: 00612649212722 (Shipper Label); 00612649212739 (Piece Label)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0275-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0269-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30
Z-0270-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30
Z-0271-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30
Z-0272-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30
Z-0273-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30
Z-0274-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30
Z-0275-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30
Z-0276-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-06	2024-10-30

Product code CAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)