Stryker Scopis ENT Software Version NOVA 3.6.0 RC16: Visual Feedback Error
Stryker recalls ENT software version NOVA 3.6.0 RC16 for visual feedback errors during sinus surgery. Affected units may show incorrect points relative to physical reference points.
Lower-risk recall
Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.
Contact the company
What happened, in plain English
Stryker is recalling a specific version of ENT software (Scopis with TGS) that shows incorrect visual feedback during surgery. This could lead to inaccurate surgical planning if the software displays points that don't match the physical reference point of the surgical instruments. Read more at govinfonow.com/recall/55666-stryker-scopis-ent-software-version-nova-3-6-0-rc16.
Source Summary by GovInfoNow · govinfonow.com/recall/55666-stryker-scopis-ent-software-version-nova-3-6-0-rc16 · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1885-2024
Cite this page
“Stryker Scopis ENT Software Version NOVA 3.6.0 RC16: Visual Feedback Error.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/55666-stryker-scopis-ent-software-version-nova-3-6-0-rc16. Based on FDA recall #Z-1885-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1885-2024%22&limit=1).
Why it’s dangerous
The software shows points that are off from the physical reference point of the surgical instruments during endoscopic sinus surgery. This could cause inaccurate surgical planning if the surgeon relies on the visual feedback to guide their instruments.
Who’s affected
Surgeons using the Stryker Scopis ENT Software version NOVA 3.6.0 RC16 for endoscopic sinus surgery. The risk is low as the software error is a visual display issue, not a physical hazard.
How to tell if you have this one
Check if your software version is NOVA 3.6.0 RC16 with product code 8000-021-002. The software is used with the Stryker Electromagnetic Navigation Unit (8000-010-003) for endoscopic sinus surgery.
- Brand
Stryker- Category
Medical device
What to do — step by step
Check Software Version
Verify your software version is NOVA 3.6.0 RC16 with product code 8000-021-002.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 55 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-1885-2024 (April 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1885-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.