Recall Z-0490-2026— Stryker Sustainability Solutions
Class II · Ongoing
Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2025-09-24. It names one FDA 510(k) clearance: K170456. Product: HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY. Reason: Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation..
- Recalling firm
- Stryker Sustainability Solutions
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-24
- Firm location
- Tempe, AZ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.