TRITON recallZ-1394-2022 · Stryker Instruments Div. of Stryker Corporation · initiated Dec 4, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Instruments Div. of Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Use error
What the company is doing
Gauss notified customers with a notification letter dated Dec 4, 2018. The letter informed customers that the IFU would be updated in order to clarify proper technique for handling sponges and the calibration placard. No action was required by the customer as the IFU updates were automatically accessible to the user through the iPad application and automatically moved to the newest revision.
Recall details
- Recall number
- Z-1394-2022
- Status
- Terminated
- Initiated by the company
- Dec 4, 2018
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 51 units
- Product code
- FQA
- Distribution
- US Nationwide.
Product description
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Code information (models, lots, serial numbers)
UDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TRITON GAUS-3Stryker Corporation · Image Processing Device For Estimation Of External Blood Loss1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page