Device product
ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
Z-2471-2026
Product summary
- Event
- Event 98854
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 36,462 packs (219,850 eaches)
- Official record key
device-enforcement:Z-2471-2026
Official wording
Reason: Potential for overpressure alerts.
Code information: 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.
Distribution pattern: 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. .
Derived failure modes
-
Unknown
Potential for overpressure alerts.