King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is… — Class II medical device recall Z-0002-2014
Terminated recall by King Systems Corp., reported 2013-10-09, distributed nationwide. On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) fr
| Recall number | Z-0002-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | King Systems Corp., Noblesville, IN, United States |
| Recall initiated | 2013-12-12 |
| Classified | 2013-10-01 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2013-11-08 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | IV1V3 |
| Model numbers | IV1V3, KLTSD415 |
Product
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-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.
Reason for recall
On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the components are the same size, part number etc. I
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0002-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.