Stryker Triton Sponge System Software Update Recalls: Clarify Sponge Handling
Stryker recalls Triton Sponge System software versions 4.6.5, 4.8.7, and 4.9.6 for updated instructions on sponge handling and calibration placards.
Lower-risk 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.
Contact the company
What happened, in plain English
Stryker is recalling specific software versions of their Triton Sponge System to clarify proper sponge handling techniques and calibration placard procedures. This update aims to improve safety and reduce confusion during surgical procedures. Read more at govinfonow.com/recall/69390-stryker-triton-sponge-system-software-update-recalls-clarify-sponge-handling.
Source Summary by GovInfoNow · govinfonow.com/recall/69390-stryker-triton-sponge-system-software-update-recalls-clarify-sponge-handling · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1394-2022
Cite this page
“Stryker Triton Sponge System Software Update Recalls: Clarify Sponge Handling.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69390-stryker-triton-sponge-system-software-update-recalls-clarify-sponge-handling. Based on FDA recall #Z-1394-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1394-2022%22&limit=1).
Why it’s dangerous
The recall involves updating instructions for proper sponge handling and calibration placard procedures. This update clarifies techniques to prevent potential errors during surgical sponge management.
Who’s affected
Surgical teams using the Triton Sponge System with software versions 4.6.5, 4.8.7, or 4.9.6 are affected. Surgeons and surgical staff handling sponges during procedures are most at risk.
How to tell if you have this one
Check if your Triton Sponge System software is version 4.6.5, 4.8.7, or 4.9.6. The product has a UDI-DI (GTIN) number 00859506006067.
- Brand
Stryker- Category
Medical device
What to do — step by step
Check Software Version
Review your Triton Sponge System software version to confirm if it is 4.6.5, 4.8.7, or 4.9.6.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 5.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to do anything with this software?
The recall does not require immediate action; it is a clarification of instructions for safer use.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1394-2022 (December 4, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1394-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.