Class II

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

Stryker Sustainability Solutions · September 24, 2025

Reason for Recall

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

Distribution

US Nationwide distribution and OUS (foreign) to country of: Canada.

States Affected

NATIONWIDE

Quantity Affected

22, 476 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0490-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.