HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device f
Pending LLM rewrite. Source: FDA_DEVICE Z-0490-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
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.
Related recalls
Same category
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
- ModerateTosoh ST AIA-Pack Testosterone Diagnostic Test Kit Recall
FDA (Devices) · 2026-07-22
- ModeratePapablic Replacement Brush Heads Recalled Due to Breakage Risk
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- SevereAbiomed Introducer Kit for Impella Heart Pump Sheath Leak Risk
FDA (Devices) · 2026-07-22