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FDAClass II · Medical device · Recalled June 24, 2026

ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall — ConMed Corporation

Hazard: Potential for overpressure alerts.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2473-2026
Brand
ConMed
Classification
Class II
Units affected
71,151 packs (426,908 eaches)
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.

Affected products

Companies & origin

Recalling firm location
Utica, NY, United States
Firm address
525 French Rd, 13502-5945

Identifying details (verbatim from the notice)

Product codes / lots
Catalog Number: iAS12-120LPI. UDI-DI: 10845854045688. Lot Numbers: 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. *OUS added 06/10/2026 expansion: 202411204, 202511075, 202511244, 202509154, 202509104, 202509264, 202508084, 2025080611, 202507284, 202507254, 202507264, 202504174, 202506274, 2025040310, 202504244, 202505144, 202501085, 202501094, 202504164, 202502214, 2024112110, 202410245, 202410285, 202411044, 2024112011, 202412105, 202411266, 202510274, 202510184, 202406226, 202406216, 202407024, 202407136, 202408066, 2024071212, 202511064, 202511065, 202509274, 202508214, 202510254, 202506124, 202503204, 202504044, 202505064, 202503075, 202501244, 202501154, 202407026, 202408194, 202407116, 202511214, 2025071010, 202505164, 202410315, 202501166, 202512124, 202408304, 202410225, 202408135, 202511074, 202509124, 202510244, 2025100310, 202507144, 202505194, 2025041710, 202501084, 202406255, 202407126, 202408195, 202411214, 202408084, 202508204, 2025040410, 202411225, 202509114, 202503064, 202406256, 202407245, 202412124, 202511204, 202509254, 202510154, 202510034, 202504046, 2025040411, 202501235, 202501256, 202510035, 202512154, 202503065, 202407105, 202408144, 202506114, 202510204, 202512114, 202503245, 202501034, 202501224, 202411215, 202507244, 202509014, 202509244, 202508284, 202511086, 202511104, 202601064, 2024121210, 202408216, 202412234, 202502114, 202504056, 202411194, 2025043010, 202506134, 202507114, 202406245, 202408164, 2025080810, 202409034, 202508264, 202406214, 202408295, 202410294, 202504304, 202506164, 202506304, 202502105, 2024121311, 202410305, 202408146, 202504214, 202501164, 202601124, 202507234, 2025041610, 202501145, 202410284, 202408064, 202408136, 202406204, 202501024, 202501025, 2024121310, 202505284, 202501234, 202411195, 202411205, 202408166, 202408176, 202505054, 202410295, 202408155, 202407154, 202407114, 202407125, 202508294, 2025110512, 202507104, 2025042110, 202502075, 202506024, 202501245, 202410304, 202410314, 2024112210, 202512234, 202505014, 202510164, 202406254, 202505304, 202502055, 2025110510, 202506136, 202506244, 202408156, 202508274, 202506254, 202504224, 202501236, 2024112211, 202408124, 202503215, 202501286, 202412144, 2024112511, 202408145, 202408065, 202501226, 202412125, 2025110410, 202510174, 202504025, 202503244, 202504036, 2025040210, 202408165. Manufactured from 14 June 2024 to 12 January 2026.
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, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, MALAYSIA, Malta, Montenegro, Netherlands, NEW ZEALAND, Norway, Oman, Palestine, PANAMA, PHILIPPINES, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, SINGAPORE, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, TAIWAN,PROVINCE OF CHINA, THAILAND, Turkey, Ukraine, UNITED ARAB EMIRATES, United Kingdom. .
Firm notified the public via
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID
98854
Recall initiated
May 14, 2026
FDA classified
June 17, 2026
FDA report date
June 24, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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