12-Instrument Sterilization Tray — Class II medical device recall Z-1544-2014
Terminated recall by Stryker Endoscopy, reported 2014-05-14. Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully
| Recall number | Z-1544-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Endoscopy, San Jose, CA, United States |
| Recall initiated | 2014-04-16 |
| Classified | 2014-05-02 |
| Reported by FDA | 2014-05-14 |
| Terminated | 2014-08-18 |
| Quantity | 2,591 trays |
| Serial numbers | 021464-2, 021464-3, 123, 1SS15327, 23027, 23398, 23542, 23846, 24073, 24511, 26445, 26843, 27419, 27701, 28646-1-1, 29005-1-1, 29129, 29670, 30250, 30384-1-1, 30919, 3218, 33226, 33961, 35728-2-1 and 57 more |
| Model numbers | 0242000012 |
Product
12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The tray features silicon device holders that secure devices during the sterilization process.
Reason for recall
Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
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-1544-2014. 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.