Agency classClass IIOur severity:High FDA (Devices)·Z-0273-2025·Announced 2024-11-06

King LTSD Oropharyngeal Airway Recalled for Unauthorized Pediatric Use

King Systems' KING LTSD oropharyngeal airway was marketed for pediatric use but lacked the required FDA clearance for that indication. Approximately 17,925 units were distributed nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall for a medical device with an unapproved indication for pediatric use. While no illnesses or injuries have been reported, marketing an airway device for pediatric patients without FDA clearance for that specific indication represents a risk-of-harm scenario.

Plain-English summary

King Systems Corp. dba Ambu, Inc. is recalling the KING LTSD oropharyngeal airway, Model KLTSD430, Size 0, a non-sterile medical device designed to be inserted through the mouth into the pharynx to maintain a patent airway.

The recall was initiated because the device exceeds the limitations of the 510(k) exemption under 21 CFR 868.9(a). Specifically, the manufacturer introduced a new indication for pediatric use without obtaining FDA clearance for that indication. This means the device was marketed for use in a pediatric population that was not evaluated or approved by the FDA.

Approximately 17,925 units were distributed nationwide. Healthcare providers and patients with this product should cease use and contact King Systems Corp. or Ambu, Inc. for instructions. No illnesses or injuries related to this device have been reported.

The recalled product

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
Manufacturer: King Systems Corp. dba Ambu, Inc.
Category: Medical Device — Airway management
Hazard: improper-indication
regulatory-violation
Affected units: 17,925

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

UD-DI: 00612649212692 (Shipper Label)
00612649212685 (Piece Label)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by King Systems Corp. dba Ambu, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · King Systems Corp. dba Ambu, Inc.

See all →

Moderate
KING LTSD Oropharyngeal Airway Kit Recalled for Unapproved Pediatric Use
FDA (Devices) · 2024-11-06
High
FDA Recalls Pediatric Oropharyngeal Airway Kit for Regulatory Non-Compliance
FDA (Devices) · 2024-11-06
Moderate
King LTSD Oropharyngeal Airway Recalled for Pediatric Indication Limitation
FDA (Devices) · 2024-11-06
High
Laryngeal Tube Device Recalled for Unapproved Pediatric Indication
FDA (Devices) · 2024-11-06
High
King LTSD Oropharyngeal Airway Recalled for Uncleared Pediatric Indication
FDA (Devices) · 2024-11-06

Same hazard · improper indication