Recall
FDAHealthMay 14, 2026

ConMed Corporation — ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide

⚠️ Potential for overpressure alerts.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
May 14, 2026

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. .

What's affected?

Product
ConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog Number: iASB12-100. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
Lot code
202510034

Additional details

Catalog Number: iASB12-100. UDI-DI: 10851885004310. Lot Numbers: 202510034, 202505134, 202507234, 202510094, 202503184, 202408306, 202407044, 202412194, 202512014, 202512024, 202410085, 202411264. *OUS added 06/10/2026 expansion: 202510034, 202412194, 202411264, 202503184, 202410085, 202507234, 202408306, 202407044, 202505134, 202512024, 202512014, 202510094. Manufactured from 14 June 2024 to 12 January 2026.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 1,261 packs (7,566 eaches).

View original FDA notice →

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