FDA Device recall Z-1394-2022
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
- FDA Device
- Class III
- terminated
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class III recall of Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 by Stryker Instruments Div, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1394-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-12-04 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
Product
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Reason
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.
Identifiers
| code_info | UDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1394-2022%22
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