FDA-Device2026-06-24Class IIPROCESSING DEFECT
ConMed AirSeal 8mm Access Port recalled for potential overpressure alerts
What this means
ConMed Corporation is recalling certain AirSeal 8mm Access Port and Low Profile Obturator devices (catalog number iAS8-100LP) used in laparoscopic surgery. The devices may generate false overpressure alerts during use. No injuries have been reported.
- Check if your facility has affected lot numbers (202509034, 202511194, 202509174, and others manufactured June 14, 2024–January 12, 2026)
- Contact ConMed Corporation for device replacement or return instructions
- Do not use affected units for new procedures
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
26,609 packs (159,657 eaches)
Manufactured in
525 French Rd, Utica, NY, United States
Products
ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS8-100LP. 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-2468-2026Want us to check the next one for you?
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