← FDA ENFORCEMENT
Z-2472-2026Class II

ConMed Corporation

Recalling firm
ConMed Corporation
Product type
Device
Status
Ongoing
Report date
2026-06-24
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. .
Firm state
NY
Product quantity
3,550 packs (21,300 eaches)
Initiated by
Voluntary: Firm initiated
Reason for recall

Potential for overpressure alerts.

Product description

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.

Code / lot 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.

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.