Z-2466-2026Class 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

Product quantity

1,261 packs (7,566 eaches)

Initiated by

Voluntary: Firm initiated

Reason for recall

Potential for overpressure alerts.

Product description

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.

Code / lot info

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.

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.