[pending] HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device f
Pending LLM rewrite. Source: FDA_DEVICE Z-0490-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.
The recalled product
- Product
- HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY
- Manufacturer
- Stryker Sustainability Solutions
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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