Triton Canister System — Class II medical device recall Z-1402-2022
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2022-07-27, distributed nationwide. Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a c
| Recall number | Z-1402-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2020-01-22 |
| Classified | 2022-07-19 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2024-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 16,700 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10859506006101, 10859506006125 |
| Model numbers | 11032, 12009 |
Product
Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation of blood loss. Used with blood bearing canisters and accessories.
Reason for recall
Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.
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-1402-2022. 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.