BEUDAMED
    FDA Enforcement Class II Ongoing

    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.

    Recall: Z-2473-2026 · Reported June 24, 2026

    Enforcement

    Recall Number
    Z-2473-2026
    Event ID
    98854
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ConMed Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    June 24, 2026
    Initiation Date
    May 14, 2026
    Classification Date
    June 17, 2026
    Address
    525 French Rd, Utica, NY, 13502-5945, United States

    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.

    Reason

    Potential for overpressure alerts.

    Code Info

    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. .

    Quantity

    71,151 packs (426,908 eaches)