# FDA recall Z-0490-2026

> **Stryker Sustainability Solutions** · Class II · device recall initiated 2025-09-24.

## 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

- **Recall number:** Z-0490-2026
- **Recalling firm:** Stryker Sustainability Solutions
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-24
- **Report date:** 2025-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0490-2026. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0490-2026. Source: US FDA. Licensed CC0.

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