CLASS II ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report

King Ltsd,Size 2, W/Suction Port Non-sterile Kit-Inserted recalled

King Systems is recalling King Ltsd,Size 2, W/Suction Port Non-sterile Kit-Inserted into a patient s pharynx, distributed nationwide in the US. The recall was initiated on 26 Sep 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUD-DI: 00612649212722 (Shipper Label); 00612649212739 (Piece Label)

Quantity recalled44755 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0275-2025
FDA event ID: 95451
Recalling firm: King Systems, Noblesville, IN
Classification: Class II
Status: Ongoing
Recall initiated: 26 Sep 2024
FDA classified: 30 Oct 2024
Reported: 6 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Sterility
Device type: Other Medical Devices

Timeline

26 Sep 2024	Recall initiated by company
30 Oct 2024	Classified by FDA	+34 days
6 Nov 2024	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Is King Ltsd,Size 2, W/Suction Port Non-sterile Kit-Inserted into a patient s pharynx recalled?

Yes. King Systems recalled King Ltsd,Size 2, W/Suction Port Non-sterile Kit-Inserted into a patient s pharynx on 26 Sep 2024. The recall is Class II and its status is Ongoing. Recall number Z-0275-2025.

Why was it recalled?

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.

Which lots are affected?

UD-DI: 00612649212722 (Shipper Label); 00612649212739 (Piece Label)

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from King Systems

All 26

Reported	Class	Recall	Company	Reason	Where
6 Nov 2024Device	CLASS II	King Ltsd,Size 2,W/Suction Port Sterile-Inserted into recalled	King Systems	Sterility	Nationwide
6 Nov 2024Device	CLASS II	King Ltsd,Size 5, W/Suction Port Sterile-Inserted into recalled	King Systems	Sterility	Nationwide
6 Nov 2024Device	CLASS II	King Ltsd,Size 0, W/Suction Port Non-sterile Kit-Inserted recalled	King Systems	Sterility	Nationwide
6 Nov 2024Device	CLASS II	King Ltsd,Size 1, W/Suction Port Non-sterile Kit-Inserted recalled	King Systems	Sterility	Nationwide
6 Nov 2024Device	CLASS II	King Ltsd,Size 5, W/Suction Port Non-sterile Kit-Inserted recalled	King Systems	Sterility	Nationwide

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