FDA-Device2026-06-24Class IIPROCESSING DEFECT
ConMed AirSeal 12mm Access Port recalled for overpressure alert risk
What this means
ConMed Corporation recalled certain AirSeal 12mm Access Ports (catalog number iASB12-100) used in laparoscopic surgery due to a potential for overpressure alerts. The affected devices were manufactured between June 2024 and January 2026, and were distributed nationwide and internationally.
- Check if your facility has inventory of ConMed AirSeal 12mm Access Port catalog number iASB12-100 with the affected lot numbers listed in the recall.
- Do not use affected units and contact your ConMed representative or the FDA for instructions on device replacement or return.
- Report any incidents related to overpressure alerts during use to ConMed and the FDA MedWatch program.
The agency's original wording
Hazard
Potential for overpressure alerts.
Intended for
Adults
Illnesses reported
None reported
Sold states
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. .
Affected count
1,261 packs (7,566 eaches)
Manufactured in
525 French Rd, Utica, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2466-2026Want us to check the next one for you?
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