CLASS II ONGOING Device recall · Reported 6 Nov 2024 · FDA Enforcement Report
King Ltsd,Size 1, W/Suction Port Non-sterile Kit-Inserted recalled
King Systems is recalling King Ltsd,Size 1, 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
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-0274-2025
- 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
- Other Reasons
- 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.
Product as listed by the FDA
KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431
Where it was distributed
Nationwide
Questions about this recall
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: 00612649212708 (Shipper Label); 00612649212715 (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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 95451This product is part of a recall event; the main page for the event is Ambu / King Ltsd, Size 0,1 W/Suction Port recalled by King Systems.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ambu / King Ltsd, Size 0,1 W/Suction Port recalled by King Systems | King Systems | Other | Nationwide | |
| CLASS II | King Ltsd,Size 1,W/Suction Port Sterile-Inserted into recalled | King Systems | Other | Nationwide | |
| CLASS II | King Ltsd,Size 2.5, W/Suction Port Non-sterile Kit-Inserted recalled | King Systems | Other | Nationwide | |
| CLASS II | King Ltsd,Size 2, W/Suction Port Non-sterile Kit-Inserted recalled | King Systems | Other | Nationwide | |
| CLASS II | King Ltsd,Size 0, W/Suction Port Non-sterile Kit-Inserted recalled | King Systems | Other | Nationwide | |
| CLASS II | King Ltsd,Size 2.5, W/Suction Port Sterile-Inserted into recalled | King Systems | Other | Nationwide | |
| CLASS II | King Ltsd,Size 2,W/Suction Port Sterile-Inserted into recalled | King Systems | Other | Nationwide |
More recalls from King Systems
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | King Ltsd,Size 2,W/Suction Port Sterile-Inserted into recalled | King Systems | Other | Nationwide |
| Device | CLASS II | King Ltsd,Size 2.5, W/Suction Port Sterile-Inserted into recalled | King Systems | Other | Nationwide |
| Device | CLASS II | King Ltsd,Size 0, W/Suction Port Non-sterile Kit-Inserted recalled | King Systems | Other | Nationwide |
| Device | CLASS II | King Ltsd,Size 2, W/Suction Port Non-sterile Kit-Inserted recalled | King Systems | Other | Nationwide |
| Device | CLASS II | King Ltsd,Size 2.5, W/Suction Port Non-sterile Kit-Inserted recalled | King Systems | Other | Nationwide |
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