BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0490-2026 · Initiated September 24, 2025

    Recall

    Recall Number
    Z-0490-2026
    Event Number
    97694
    Firm
    Stryker Sustainability Solutions
    FEI Number
    3009350690
    Product Code
    NLQ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 24, 2025
    Posted
    November 12, 2025
    Address
    1810 W Drake Dr, Tempe, AZ, 85283-4327

    Description

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

    Reason

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

    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.

    Distribution

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

    Quantity

    22, 476 units