8000-021-002 — Class II medical device recall Z-1885-2024
Ongoing recall by Stryker Leibinger GmbH & Co. KG, reported 2024-05-29, distributed nationwide. Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show t
| Recall number | Z-1885-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Leibinger GmbH & Co. KG, Freiburg Im Breisgau, Germany |
| Recall initiated | 2024-04-04 |
| Classified | 2024-05-23 |
| Reported by FDA | 2024-05-29 |
| Distributed | Nationwide (US) |
| Quantity | 705 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07613327514179 |
| Serial numbers | 0244-B, 0251-B, 0252-B, 0259-B, 0260-B, 0263-B, 0271-B, 0280-B, 0281-B, 0282-B, 0285-B, 0287-B, 0291-B, 0292-B, 0303-B, 0304-B, 0306-B, 0307-B, 0308-B, 0309-B, 0310-B, 0313-B, 0318-B, 0320-B, 0322-B and 475 more |
Product
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery.
Reason for 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1885-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.