BEUDAMED
    FDA Recall Open, Classified

    HarmonyAIR A-Series Surgical Lighting System

    Recall: Z-2448-2026 · Initiated May 15, 2026

    Recall

    Recall Number
    Z-2448-2026
    Event Number
    98767
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    FSY
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    May 15, 2026
    Posted
    June 15, 2026
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    HarmonyAIR A-Series Surgical Lighting System

    Reason

    There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads.

    Action

    An URGENT MEDICAL DEVICE RECALL notification letter dated 5/1/26 was sent to customers. STERIS Action All affected Customers will be contacted by a STERIS Service Technician to arrange an onsite inspection of their lighting system(s) to perform the correction as soon as possible. For the paint issue, each affected lighting system will undergo a full visual inspection for any signs of paint delamination; as needed a service kit will be installed to prevent paint chipping from occurring or if deemed necessary replaced. For the button issue, each affected lighting system will undergo inspection for any signs of potential separation from the light head and handle. Buttons failing this inspection will be replaced. User Action Users can continue to use their lighting system(s) prior to completion of the correction. Users are reminded to ensure no excess fluids remain on light head during or after cleaning, per the Operator Manuals. Should any issues be observed prior to the correction being completed, users should submit a complaint by contacting STERIS Customer Service at 1-800-548-4873. Users are also reminded to report any adverse events via FDA s MedWatch Database should an event occur. We apologize for any inconvenience this matter may cause, and as always, STERIS is dedicated to supporting our products and valued Customers. If you have questions regarding this matter, please contact your local Account Manager.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Canada, India, New Zealand, Panama.

    Quantity

    4138 units