FDA-Device2026-06-24Class IIPROCESSING DEFECT
ConMed AirSeal 8mm Access Port recalled for potential overpressure alerts
What this means
ConMed Corporation is recalling specific lots of its AirSeal 8mm Access Port with Low Profile Obturator (catalog number iAS8-120LP) used in laparoscopic surgery. The device may generate overpressure alerts that could affect proper operation during procedures. The recall affects approximately 55,694 packs distributed nationwide and internationally.
- Check if your facility has received affected lot numbers (manufactured June 2024 – January 2026; see lot number list in full recall notice).
- Stop using affected units immediately.
- Contact ConMed or your supplier for instructions on device return or replacement.
- Notify your surgical team and device management staff of the recall.
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
55,694 packs (344,166 eaches)
Manufactured in
525 French Rd, Utica, NY, United States
Products
ConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS8-120LP. 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-2467-2026Want us to check the next one for you?
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