Recall Record: Class II Recall: 8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware… by Stryker Leibinger GmbH & Co. KG

Key facts

What this classification means

A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of 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. should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Stryker Leibinger GmbH & Co. KG. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Stryker Leibinger GmbH & Co. KG should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Stryker Leibinger GmbH & Co. KG directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Stryker Leibinger GmbH & Co. KG’s FDA history

Argus HQ has recorded 3 total FDA actions tied to Stryker Leibinger GmbH & Co. KG: 0 warning letters, 3 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Has Stryker Leibinger GmbH & Co. KG had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 3 total FDA actions tied to Stryker Leibinger GmbH & Co. KG, including 3 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-1885-2024.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

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