# FDA recall Z-1394-2022

> **Stryker Instruments Div. of Stryker Corporation** · Class III · device recall initiated 2018-12-04.

## 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.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** Z-1394-2022
- **Recalling firm:** Stryker Instruments Div. of Stryker Corporation
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-12-04
- **Report date:** 2022-07-27
- **Termination date:** 2024-03-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1394-2022

## Citation

> MORVS. FDA recall Z-1394-2022. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-1394-2022. Source: US FDA. Licensed CC0.

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