ConMed AirSeal 5mm Access Port and Low Profile recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number: iAS5-100LP. UDI-DI: 10845854045626. Lot Numbers: 202509104, 202502195, 202502255, 202503115, 202503205, 202504084, 202503114, 202503035, 202503204, 202510214, 202511044, 202511055, 202510144, 202510284, 202510134, 202511184, 202510294, 202510224, 202511066, 202511124, 202511144, 202511154, 202505284, 202506064, 202506204, 202507014, 202504074, 202507154, 202507294, 202507164, 202507284, 202506194, 202507024, 202505194, 202504014, 202503215, 202505274, 202511134, 202509154, 202509294, 202508274, 202509234, 202510014, 202508044, 202508134, 202508154, 202509114, 202411224, 202509224, 202506216, 202410074, 202410155, 202410154, 202410224, 202412045, 202501064, 202509024, 202503116, 202504024, 202503124, 202502274, 202502175, 202411205, 202407094, 202503206, 202502264, 202408224, 202409105, 202411264, 202506074, 202412164, 202509304, 202601124, 202502184, 202512024, 202502194, 202506094, 202509014, 202508264, 202509124, 202506184, 202506234, 202507074, 202508014, 202508184, 202411255, 202411204, 202510074, 202408305, 202406215, 202501296, 202410025, 202406205, 202411214, 202410284, 202409245, 202410164, 202409186, 202407194, 202410084, 202412134, 202409246, 202502114, 202502054, 202502045, 202411254, 202409244, 202502116, 202407254, 202406285, 202502105, 202412035, 202406214, 202408135, 202502265, 202511114, 202409235, 202509244, 202408064, 202503214, 202503046, 202507214, 202512014, 202409286, 202502276, 202501035, 202501036, 202504164, 202503055, 202507034, 202408134, 202407095, 202412065. *OUS added 06/10/2026 expansion: 202409244, 202511044, 202511066, 202511055, 202508274, 202509104, 202506194, 202508134, 202508154, 202507294, 202505194, 202507014, 202507024, 202503114, 202503215, 202504014, 202412164, 202412135, 202501036, 202501294, 202501064, 202412065, 202411225, 202408064, 202412145, 202501065, 202510014, 202407014, 202505274, 202410155, 202406205, 202508044, 202510294, 202511144, 202410094, 202407254, 202510144, 202509294, 202509154, 202507154, 202506204, 202502195, 202501035, 202502045, 202411254, 202409104, 202409245, 202406214, 202504074, 202407194, 202408224, 202406215, 202503115, 202510134, 202506064, 202503204, 202503035, 202509234, 202502114, 202507284, 202505284, 202501295, 202407094, 202502255, 202408134, 202510284, 202511134, 202507164, 202504084, 202412044, 202510074, 202511124, 202508184, 202412134, 202510224, 202510214, 202509304, 202506234, 202509024, 202507034, 202507074, 202507044, 202510064, 202509124, 202510034, 202508264, 202506094, 202506184, 202502105, 202502274, 202503065, 202503205, 202503226, 202509224, 202503055, 202411214, 202512024, 202410154, 202506216, 202503116, 202503124, 202601124, 202412045, 202411224, 202410224, 202509014, 202409105, 202410074, 202509114, 202503206, 202502184, 202509244, 202502276, 202411264, 202502116, 202408215, 202411195, 202408305, 202408144, 202411204, 202410025, 202408135, 202409246, 202410084, 202406285, 202502264, 202503046, 202507214, 202502054, 202502175, 202410284, 202410164, 202502265, 202507174, 202504024, 202411255, 202508014, 202410035, 202502194, 202410255, 202409024, 202410045, 202408264, 202410235, 202406244, 202409286, 202408304, 202407095, 202408065, 202406284, 202511114, 202502185, 202502186, 202412054, 202411215, 202408075, 202409175, 202502196, 202503214, 202504164, 202411205, 202409174, 202409235, 202406204. Manufactured from 14 June 2024 to 12 January 2026.

Product

ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack.…

Recalling firm

ConMed Corporation

Quantity

36,462 packs (219,850 eaches)

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. .

Recall date

June 24, 2026

Classification

Class II

Status

Ongoing

Agency

FDA (device)