ConMed Corporation: ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip recall

Recall details

FDA classification

Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.

Status

Ongoing

Codes, lots and dates

Catalog Number: iAS8-100LP. UDI-DI: 10845854045718. Lot Numbers: 202509034, 202511194, 202509174, 202506264, 202506254, 202506274, 202507074, 202505096, 202507244, 202508124, 202508194, 202507084, 202504294, 202505074, 202504304, 202504155, 202505064, 202505094, 202505204, 202509244, 202511184, 2025102210, 202508254, 2025111110, 202510154, 202508054, 202508114, 202507254, 202509084, 202509054, 202411015, 202408155, 202503016, 202504234, 202505264, 202501134, 202411124, 202501135, 202412195, 202411305, 202511274, 202509274, 202511284, 202504284, 202504224, 202503194, 202504085, 202508184, 202510304, 202409034, 202409095, 202409094, 202408085, 202410104, 202506304, 202506054, 202510094, 202409025, 202410175, 202508264, 202408095, 202408125, 202411115, 202411014, 202506044, 202509194, 202511264, 202408274, 202412205, 202412025, 202501236, 202501235, 202501244, 202503156, 202503145, 202503144, 202504084, 202408094, 202408084, 202410105, 202502066, 202501094, 202509184, 202408275, 202408194, 202507144, 202507154, 202412024, 202501234, 202411295, 202504094, 202503196, 202503125, 202503126, 202503034, 202504145, 202408165, 2025081811, 202408154, 202503264, 202502055, 202411294, 202412106, 202601074, 2026010711, 202501225, 202412204, 202501245, 202409106, 202410315. *OUS added 06/10/2026 expansion:202408284, 202509244, 202507254, 202508054, 202508194, 202505064, 202504294, 202504155, 202504304, 202501085, 202501146, 202501274, 202501224, 202410314, 202410315, 202509034, 2025111110, 202509174, 202507244, 202508124, 202506274, 202505204, 202506254, 202503144, 202409106, 202511184, 202505096, 202501225, 202510154, 202408165, 202508114, 202508254, 202408085, 202507084, 202505094, 202507074, 202503194, 202501135, 202412205, 202412204, 202408084, 202411295, 202412106, 202509054, 202509084, 2025102210, 202504084, 202503196, 202504145, 202501094, 202408164, 202411124, 202503125, 202408094, 202505074, 202504224, 202411294, 202507144, 202408095, 202506304, 202511274, 202508184, 202503264, 202411115, 202504234, 202506264, 202501244, 202503034, 202509184, 202501236, 202411305, 202510304, 202505264, 202502055, 202412025, 202412195, 202410175, 202506054, 2025081811, 202503016, 202409034, 202409094, 202501134, 202507154, 202511284, 202506044, 202510094, 202411015, 202503145, 202408274, 202511264, 202411014, 202408155, 202509274, 202503156, 202508264, 202408194, 202504094, 202501234, 202408275, 202408154, 202408075, 202511194, 202504085, 202501245, 202412024, 202410115, 202412126, 202409025, 202409095, 202501235, 202410104. Manufactured from 14 June 2024 to 12 January 2026.

Quantity

26,609 packs (159,657 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. .

Recalling firm

ConMed Corporation, Utica, NY

Voluntary or mandated

Voluntary: Firm initiated

Recall started

2026-05-14