The Recall Desk
HighFDA (Devices)·Z-0275-2025·Announced 2024-11-06

King LTSD Oropharyngeal Airway Recalled for Uncleared Pediatric Indication

King Systems is recalling the King LTSD Size 2 oropharyngeal airway because it was distributed with a pediatric indication that lacks proper FDA 510(k) clearance, exceeding exemption limits.

What this means for you

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 device being distributed with a pediatric use indication that lacks proper 510(k) clearance, representing a risk-of-harm situation for a critical airway device. No illnesses or injuries have been reported.

Plain-English summary

King Systems Corp. dba Ambu, Inc. is recalling the King LTSD Size 2 with Suction Port Non-Sterile Kit nationwide. This oropharyngeal airway is inserted into the patient's pharynx through the mouth to provide and maintain a patent airway.

The recall is due to a regulatory violation: the device was distributed with an indication for pediatric use that exceeds the limitations of the 510(k) exemption under 21 CFR 868.9(a). The device's 510(k) clearance did not include evaluation for this pediatric use indication.

Approximately 44,755 units have been distributed nationwide. The affected units can be identified by Universal Device Identifier (UDI) codes UD-DI: 00612649212722 (Shipper Label) and 00612649212739 (Piece Label).

Healthcare providers and facilities using this device should contact King Systems Corp. dba Ambu, Inc. for instructions and further information regarding this recall.

The recalled product

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
Manufacturer
King Systems Corp. dba Ambu, Inc.
Category
Medical Device — Airway Management
Hazard
Affected units
44,755

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: 00612649212722 (Shipper Label)
  • 00612649212739 (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 →

Related recalls

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

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