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Recall Observatory FDA recall evidence

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

May 14, 2026

Class II

Product summary

Firm
ConMed Corporation
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

    reason.no_named_rule · v1.0.0

    Potential for overpressure alerts.