Z-1394-2022Class III

Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6

Name: Z-1394-2022 Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2018-12-04
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2018-12-04 / Terminated / root cause: labeling and UDI

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 on 2018-12-04. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1394-2022
Classification: Class III
Status: Terminated
Initiated: 2018-12-04
Posted: 2022-07-15
Terminated: 2024-03-11
Recalling firm: Stryker Corp.
Product: Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Product code: FQA Scale, Surgical Sponge
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.
Root cause tag: labeling and UDI
FDA root cause: Use error
Action: 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.
Quantity in commerce: 51 units
Distribution: US Nationwide.
Product codes and lots: UDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1394-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1394-2022	Class III	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-15

Product code FQA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)