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ConMed Corporation: ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 6 units per

Medical DevicesSource: FDA (device) · Date: 2026-06-24

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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 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 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: iAS12-150LPI. UDI-DI: 10845854052006. Lot Numbers: 202509234, 202506104, 202505074, 202503204, 202510094, 202510144, 202508194, 202506244, 202512054, 202512234, 202511224, 202504164, 202504074, 202407294, 202511214, 202410254, 202512184, 202412175, 202407115, 202411055, 202411284, 202408235, 202411274, 202502275. *OUS added 06/10/2026 expansion: 202510144, 202510094, 202506244, 202509234, 202504074, 202412175, 202408235, 202407294, 202508194, 202410254, 202408234, 202503204, 202506104, 202411055, 202505074, 202504164, 202512184, 202411274, 202511224, 202511214, 202601124, 202502275, 202411284, 202512054, 202407115. Manufactured from 14 June 2024 to 12 January 2026.
Product quantity
3,550 packs (21,300 eaches)
Voluntary mandated
Voluntary: Firm initiated
City
Utica
State
NY
Country
United States
Event id
98854
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