ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip Medical Device Recalled: Class II Recall Explained

Overview

A medical device recall is an action taken to correct or remove a device from the market when it may pose a health risk or fails to perform as intended. Device recalls range from a simple software patch or a labeling correction to a full removal of the product from circulation, depending on how serious the underlying issue is.

This specific medical device recall involving ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip is classified as Class II, and was reported on June 24, 2026 by ConMed Corporation.

The sections below explain, in plain language, what is known about this medical device recall, who it may affect, and what steps patients and caregivers can reasonably take. This article is an independent summary written for educational purposes and is not a substitute for the official FDA notice linked at the end of this page.

What Happened

ConMed Corporation initiated action on ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip on June 24, 2026 after identifying a quality or safety concern identified by the manufacturer or the FDA. The action affects specific lots or units of this device rather than every unit ever produced, so not every package on the market is necessarily involved.

The action is described in FDA records as voluntary: firm initiated, and its current status in FDA records is listed as "Ongoing". Recall status can change as the firm works through correction or removal, so the most current information is always the official FDA recall record linked below.

Affected Products

The product identified in this notice is ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, manufactured or distributed by ConMed Corporation.

FDA records describe the affected product as: 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.

Identifying details on record include specific lot numbers, batch codes, or serial numbers documented as Catalog Number: iASB12-100. UDI-DI: 10851885004310. Lot Numbers: 202510034, 202505134, 202507234, 202510094, 202503184, 202408306, 202407044, 202412194, 202512014, 202512024, 202410085, 202411264. *OUS added 06/10/2026 expansion: 202510034, 202412194, 202411264, 202503184, 202410085, 202507234, 202408306,…; a reported quantity of 1,261 packs (7,566 eaches); distribution reported as 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,…; origin or reporting location of Utica, NY, United States. If you have this product, compare it against these identifiers before assuming it is affected — many recalls apply to only a subset of lots, not an entire product line.