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Open, Classified

HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed Device for Single Use, STERILEEO, RX ONLY

FDA Recall Z-0490-2026 · Posted 2025-11-12

Recall StatusOpen, Classified
Product CodeNLQ
Date Initiated2025-09-24
Product Quantity22, 476 units

Reason for Recall

Due to manufacturing issue, reprocessed shears, may become stuck in the "on position" resulting in continuous activation.

Firm Action

On September 23, 2025, Stryker issued an "Urgent: Medical Device Recall" notification dated September 22, 2025, to affected consignees. Styker asked consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product (Attachment B). Segregate the affected products, quarantine and discontinue use. 3. Please complete and return the Business Reply Form to [email protected] or use the QR Code on Attachment A. Response is required. a. If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. For any additional information or questions please reach out to [email protected] or Stryker Customer Service at 800-624-4422.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution and OUS (foreign) to country of: Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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