ConMed Corporation recalls ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip

Potential for overpressure alerts.

ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

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.

• FDA enforcement recordOfficial FDA database entry for Z-2466-2026
• FDA 510(k) clearance · K143404The device's official FDA premarket clearance record
• FDA device classification · HIFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 884.1730The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find ConMed CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.