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FDA (Device enforcement)Recalled 2026-05-14class ii

ConMed Corporation: ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 6 units per pack. Disposable Endoscopic Trocar and C

Hazard

Potential for overpressure alerts.

Details from the source

Reason for recall: Potential for overpressure alerts. 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 Quantity: 147,013 packs (882,078 eaches) Lot/code info: Catalog Number: iAS12-100LPI. UDI-DI: 10845854045640. Lot Numbers: 2025082210, 202502265, 202601074, 202512034, 202601084, 202512194, 202512184, 202512204, 202512224, 202512024, 2026010610, 2025100710, 202512094, 202512174, 2025121810, 202510214, 2026010511, 202510024, 202510104, 202510224, 202510084, 2025121710, 202510064, 202512104, 202512164, 202512064, 202512084, 202512054, 202512044, 202512154, 202510014, 202511144, 202511254, 202511264, 202510074, 202510144, 202511124, 202509094, 202509194, 202509294, 2025093010, 202509304, 202511134, 202511194, 202509084, 2025102310, 202510294, 202510304, 202510314, 202511046, 202511114, 2025101510, 202511154, 202511184, 202509184, 202510284, 202509174, 202511014, 202511044, 202511054, 202509044, 202509164, 202510274, 2025082210, 2025101310, 202509224, 2025092910, 202510134, 2025100610, 202508194, 202508234, 202509054, 202508184, 2025082110, 202508224, 202508144, 2025082010, 2025081110, 202508114, 202508134, 202508154, 202508054, 202508074, 2025080610, 202508254, 202507304, 202508064, 202507214, 202507224, 2025072410, 2025072510, 2025072810, 2025072910, 202507184, 202507284, 2025070910, 2025071010, 202507174, 202507154, 202507164, 2025072310, 2025071410, 2025070810, 202507084, 202507094, 202507144, 2025070710, 202507014, 202506234, 202507044, 2025070210, 202507024, 2025062310, 2025060610, 202506064, 2025060910, 202506094, 202506184, 2025060510, 202506054, 2025060410, 202507045, 202506044, 202506174, 202506034, 202506194, 2025062010, 20

UPC codes

10845854045640

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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