Recall Z-2465-2026 ยท HIF Insufflator, Laparoscopic
ConMed Corporation
ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
| Date | Jun 17, 2026 (initiated May 14, 2026) |
| Status | Open, Classified |
| Reason | Potential for overpressure alerts. |
| Root cause | Process change control |
| 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 d |
| Quantity | 891 packs (5,346 eaches) |
| Distribution | Nationwide distribution. International distribution to Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, CHILE, CHINA, COLOMBIA, Croatia, Denmark, DOMINICAN REPUBLIC, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, HONG KONG, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143404 | SurgiQuest AirSeal iFS System Surgiquest, Inc., Mar 20, 2015 |