CLASS III Device recall · Reported 25 Sep 2013 · FDA Enforcement Report
King Lt-d Oropharyngeal Airways The King Lt-d is intended recalled
King Systems is recalling King Lt-d Oropharyngeal Airways The King Lt-d is intended for use in adult patients (in, distributed in New York. The recall was initiated on 3 Sep 2013 and the FDA has classified it as Class III.
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-2255-2013
- FDA event ID
- 66185
- Recalling firm
- King Systems, Noblesville, IN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Sep 2013
- FDA classified
- 19 Sep 2013
- Reported
- 25 Sep 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 3 Sep 2013 | Recall initiated by company | |
| 19 Sep 2013 | Classified by FDA | +16 days |
| 25 Sep 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Where it was distributed
Distributed in NY.
Questions about this recall
Why was it recalled?
Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious.
Which lots are affected?
Part Number KLTD2125 Lot Number I10RG
Where was it sold?
Distributed in NY.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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