Finished Goods Box of 50 Inserts and Scanning Labels for Medivac… — Class II medical device recall Z-1184-2023
Ongoing recall by Stryker Corporation, reported 2023-03-08, distributed nationwide. Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate bl
| Recall number | Z-1184-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2023-01-25 |
| Classified | 2023-02-27 |
| Reported by FDA | 2023-03-08 |
| Distributed | Nationwide (US) |
| Quantity | 101 units |
| Reason classes | labeling, software |
| UPC / GTIN / UDI-DI | 10859506006125 |
| Lot numbers | M2110004, M2201002, M2202001, M2203002, M2206001 |
| Model numbers | 12010 |
Product
Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L Catalog Number: FG 12010. Intended adjunct in the estimation of blood loss.
Reason for recall
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.
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-1184-2023. 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.