BEUDAMED
    FDA Recall Open, Classified

    ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    Recall: Z-2474-2026 · Initiated May 14, 2026

    Recall

    Recall Number
    Z-2474-2026
    Event Number
    98854
    Firm
    ConMed Corporation
    FEI Number
    3001451571
    Product Code
    HIF
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    May 14, 2026
    Posted
    June 17, 2026
    Address
    525 French Rd, Utica, NY, 13502-5945

    Description

    ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

    Reason

    Potential for overpressure alerts.

    Action

    ConMed notified consignees on about 05/14/2026 via emailed and mailed letter titled URGENT: Medical Device Correction. Consignees were made aware of the issue and risk associated with the issue. They were instructed that a replacement AirSeal disposable should be available prior to procedures in order to minimize potential delays. Before initiating insufflation, the user should ensure the tubing is properly connected between the AirSeal tube set and Airseal Access Ports. If the connection cannot be securely tightened and the overpressure alert cannot be resolved, please replace the affected device. Detailed instructions were provided on how to connect the AirSeal tube set and Airseal Access Ports. Consignees were also instructed to review inventory for affected units, place a copy of the provided Instructions for Use, Part No. AS-DIS-IFU, Rev. B with any inventory in possession with an active expiration date, contact all applicable departments and facilities that may have received affected products for awareness, and complete and return the medical device response form. If further information relevant to this issue becomes necessary CONMED will communicate as such.

    Distribution

    Nationwide distribution

    Quantity

    50,241 packs (301,446 eaches)