Recall Z-2469-2026

Reason for recall

Potential for overpressure alerts.

FDA-determined cause: Process change control

Action taken

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. On about 06/04/2026 ConMed expanded their recall to include internationally distributed units. The letter sent included the same instructions.