Medical device recalls Moderate risk

Stryker Sustainability Solutions recalls HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEE…

Recall date
September 24, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0490-2026
FDA classification
Class II
Brand / firm
Stryker Sustainability Solutions
Sold / distributed
US Nationwide distribution and OUS (foreign) to country of: Canada.

Why it was recalled

Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY

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