King LTSD Oropharyngeal Airway Recalled for Pediatric Indication Limitation
King Systems Corp. is recalling 31,457 units of King LTSD oropharyngeal airways because the device exceeded 510(k) exemption limitations by introducing a new pediatric indication.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text cites a regulatory compliance issue (exceeding 510(k) limitations) rather than a specific physical defect or reported injury. Per the rubric, this aligns with a voluntary precautionary recall or minor regulatory error, warranting a Moderate severity score.
Plain-English summary
King Systems Corp. dba Ambu, Inc. is recalling 31,457 units of the King LTSD, Size 2.5, with Suction Port Sterile oropharyngeal airway (Model/Catalog Number: KLTSD4225). The product was distributed nationwide.
The recall was initiated because the device exceeded the limitations of the 510(k) exemption under 21 CFR 868.9(a). Specifically, the device introduced a new indication for pediatric use in an oropharyngeal airway, which requires a different regulatory pathway than the exemption allows.
Healthcare providers and facilities should stop using the affected units and contact the recalling firm for further instructions. The affected units are identified by UD-DI codes 00612649210193 (Shipper Label) and 00612649210209 (Piece Label).
The recalled product
- Product
- KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
- Manufacturer
- King Systems Corp. dba Ambu, Inc.
- Affected units
- 31,457
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: 00612649210193 (Shipper Label)
- 00612649210209 (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
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