Triton Sponge System — Class III medical device recall Z-1394-2022
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2022-07-27, distributed nationwide. Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify pro
| Recall number | Z-1394-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2018-12-04 |
| Classified | 2022-07-15 |
| Reported by FDA | 2022-07-27 |
| Terminated | 2024-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 51 units |
| UPC / GTIN / UDI-DI | 00859506006067 |
Product
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Reason for recall
Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.
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-1394-2022. 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.