Class II — King Systems Corp.
| Recalling firm | KING SYSTEMS |
|---|---|
| Registered facility | KING SYSTEMS CORPORATION. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| 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. |
| Quantity | 1 case; 5 units |
| Distribution | USA Nationwide Distribution in the state of NY |
| Initiated | 2013-12-12 |
| Classified | 2013-10-01 |
| Terminated | 2013-11-08 |
| Recall number | Z-0002-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — King Systems Corp. (Z-0002-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66189/
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