CLASS III Device recall · Reported 27 Jul 2022 · FDA Enforcement Report

Triton Sponge System recalled by Stryker Instruments Div. of

Stryker Instruments Div. of Stryker is recalling Triton Sponge System (, distributed nationwide in the US. The recall was initiated on 4 Dec 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesUDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6

Quantity recalled51 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1394-2022
FDA event ID: 90448
Recalling firm: Stryker Instruments Div. of Stryker, Portage, MI
Classification: Class III
Status: Terminated
Recall initiated: 4 Dec 2018
FDA classified: 15 Jul 2022
Reported: 27 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

4 Dec 2018	Recall initiated by company
15 Jul 2022	Classified by FDA	+1319 days
27 Jul 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

US Nationwide.

Nationwide

Questions about this recall

Is Triton Sponge System ( recalled?

Yes. Stryker Instruments Div. of Stryker recalled Triton Sponge System ( on 4 Dec 2018. The recall is Class III and its status is Terminated. Recall number Z-1394-2022.

Why was it 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.

Which lots are affected?

UDI-DI (GTIN): 00859506006067; Systems running software versions 4.6.5, 4.8.7, 4.9.6

Where was it sold?

US Nationwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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