ConMed Corporation: ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per p
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- ConMed Corporation
- Product
- ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
- Reason / hazard
- Potential for overpressure alerts.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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 initiated
- 2026-05-14
- Code info
- 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.
- Product quantity
- 26,609 packs (159,657 eaches)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Utica
- State
- NY
- Country
- United States
- Event id
- 98854
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