ConMed AirSeal Access Port Recall Due to Overpressure Alerts

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

ConMed Corporation is recalling 71,151 packs of its AirSeal 12mm Access Port and Low Profile Obturator due to potential overpressure alerts.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on August 2, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.

What Happened

ConMed Corporation initiated a voluntary recall of specific lots of the ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip due to potential for overpressure alerts.

Which Products Are Affected

The recall covers ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length (Catalog Number: iAS12-120LPI). UDI-DI: 10845854045688. Affected lot numbers include 202506164, 202507144, 202506274, 202506136, 202506124, 2025071010, 202507114, 202506244, 202505194, 202505164, 202505064, 202505144, 202509114, 202508204, 202509124, 202510184, 202509274, 202511064, 202509254, 202509264, 202510254, 202510274, 202508294, 202509104, 202508214, 202509154, 202508084, 202507264, 202507254, 2025080611, 202507284, 202512124, 202511204, 202511214, 202511244, 202512134, 2025100310, 202510034, 202510154, 202511065, 202511075, 202511074, 202510244, 202510174, 202502214, 202503204, 202503075, 202503064, 202504244, 202504025, 2025040310, 2025040411, 202504046, 202503215, 202503244, 202504044, 202501164, 202501244, 202501235, 202506134, 202406204, 202406245, 202408154, 202502194, 202501145, 202505054, 202504036, 202412134, 202501274, 202408095, 202407316, 202410305, 202410244, 202506254, 202508274, 202509244, 202410234, 202411045, 202409035, 202407106, 202506304, 202512104, 202510204, 202501225, 202406214, 2025040210, 2025042110, 2025080810, 202508264, 202408135, 202410315, 202410295, 202408214, 202408294, 202507234, 202505304, 202505294, 202407155, 202408204, 202408206, 202406195, 202503065, 202502244, 202501095, 202504305, 202511086, 2024111911, 202501144, 2025110410, 2025110510, 202510164, 202511104, 2025122310, 202504304, 202501166, 202502184, 202407104, 202406215, 202406206, 202506264, 202410255, 202508284, 202507244, 202408015, 202505154, 202407305, 202411236, 2024112210, 202412105, 2025110512, 202501224, 202512154, 202407114, 202504294, 2025111910, 202407105, 202406266, 202501104, 202501275, 202503086, 2025040211, 2025111810, 2025041610, 2025110511, 202411054, 202408164, 202507104, 202408065, 202501286, 202503114, 202503214, 202412235, 202506024, 2024112111, 2024112010, 202505274, 202410304, 202411015, 202410225, 202408125, 202408205, 202409034, 202408165, 202510035, 202408155, 202408296, 202407154, 202407124, 202408064, 202406284, 202406205, 202601064, 2025122210, 2025111410, 202511066, 202411265, 202411225, 202411224, 202506104, 202408176, 202410294, 202512234, 202407015, 202407014, 202407125, 202504224, 202505014, 202411195, 202502064, 202411014, 202408094, 202411216, 202411214, 202504214, 202507094, 202406285, 202406244, 202502205, 202503205, 2024112610, 202412144, 202410235, 202411255, 202501246, 202408106, 202408224, 202407254, 202407024, 202504056, 202503245, 202501245, 202502075, 202501234, 202502114, 2024112011, 202411206, 202412135, 202406275, 202501024, 202411276, 202412124, 2024112211, 2024121210, 2025102310, 202512114, 202601055, 2025080710, 202506114, 202505284, 202505176, 202407314, 202408144, 202408134, 202410245, 202411194, 202411254, 2024121310, 202501025, 202501155, 202412114, 202408084, 202501086, 202502204, 202501034, 202412226, 202406254, 202509014, 2025100210, 202511076, 202503195, 202412164, 202407256, 202407116, 202411226, 202406286, 202407136, 202408194, 2025081110, 202411205, 202408146, 202411264, 202412234, 202411215, 202406226, 2025040710, 202501256, 202502055, 202410314, 202410284, 202408295, 202408145, 202408136, 202501154, 202502105, 202501236, 202411266, 202408124, 2024121311, 202503105, 2025040311, 202406255, 202407095, 202412125, 2024112510, 2025043010, 2024112110, 2024112511, 202408156, 202501226, 202408216, 202501085, 202407026, 2026010511, 2024071212, 202407126, 202410285, 202408166, 202406256, 202504174, 2024121211. Manufactured from June 14, 2024 to January 12, 2026. Total affected: 71,151 packs (426,908 eaches). Distributed nationwide in the United States and internationally.

What You Should Do

The recalling firm, ConMed Corporation, notified customers via email, fax, letter, press release, telephone, or visit. Consumers should refer to the firm's instructions for the recalled devices.

Why This Matters

The Class II recall involves a laparoscopic access port used with carbon dioxide insufflators, where overpressure alerts could occur during procedures.

Source

FDA recall number Z-2473-2026. Event ID 98854. Recalling firm: ConMed Corporation, 525 French Rd, Utica, NY 13502-5945.

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
ConMed Corporation is recalling 71,151 packs of its AirSeal 12mm Access Port and Low Profile Obturator due to potential overpressure alerts.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.