FDA recall Z-0490-2026

Stryker Sustainability Solutions · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2025-09-24
Report date
2025-11-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0490-2026