HARMONIC FOCUS Shears + Adaptive Tissue Technology — Class II medical device recall Z-0490-2026
Ongoing recall by Stryker Sustainability Solutions, reported 2025-11-19, distributed nationwide. Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous
| Recall number | Z-0490-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2025-09-24 |
| Classified | 2025-11-12 |
| Reported by FDA | 2025-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| UPC / GTIN / UDI-DI | 37613327348249 |
| Lot numbers | 16275164, 16284043, 16288055, 16294327, 16296918, 16301496, 16305751, 16306347, 16306436, 16316531, 16316651, 16342389, 16343642, 16346325, 16346612, 16347602, 16348678, 16349187, 16353884, 16355545, 16357189, 16360679, 16363788, 16366396, 16367903, 16368245, 16375951, 16376461, 16378500, 16380079, 16382574, 16383957, 16386402, 16399914, 163XXXXX, 16405308, 16407386, 16408732, 16410690, 16413617 and 163 more |
| Model numbers | HAR9F |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0490-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.