Stryker Instruments Div. of Stryker Corporation: Medical Device Recall in 2022 - (Recall #: Z-1394-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: December 4, 2018

Date Posted: July 27, 2022

Recall Number: Z-1394-2022

Event ID: 90448

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.

Status: Terminated

Product Quantity: 51 units

Code Information:

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

Distribution Pattern:

US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated