The Recall Desk
ModerateFDA (Devices)·Z-1394-2022·Announced 2022-07-27

Triton Sponge System Software Instructions Updated for Proper Sponge Handling

Stryker is updating the Instructions for Use for the Triton Sponge System software (versions 4.6.5, 4.8.7, 4.9.6) to clarify proper handling technique for sponges and calibration placard. The FDA Class III recall affects 51 units distributed nationwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall involving an instructional update with no reported illnesses, injuries, or deaths. The recall is precautionary and addresses documentation guidance for proper handling rather than a confirmed defect or adverse event.

Plain-English summary

The Triton Sponge System (Software, GAUS-3) is a medical device manufactured by Stryker Instruments Division of Stryker Corporation. The FDA issued a Class III recall of software versions 4.6.5, 4.8.7, and 4.9.6.

Gauss Surgical is updating the Instructions for Use (IFU) to clarify proper technique for handling sponges and the calibration placard.

The recall affects 51 units distributed throughout the United States. Healthcare facilities using the affected software versions should obtain the updated IFU.

The recalled product

Product
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Surgical Sponge System
Hazard
  • improper-use

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category