FDA-Device2026-06-24Class IIPROCESSING DEFECT
ConMed AirSeal 12mm Access Port recalled for overpressure alert malfunction
What this means
ConMed has recalled certain lots of its AirSeal 12mm Access Port with Low Profile Obturator (a surgical instrument used in minimally invasive laparoscopic procedures) due to a potential malfunction in the overpressure alert system. The affected devices may fail to properly alert during elevated pressure conditions.
- Check if your facility has inventory matching catalog number iAS12-120LPI with the listed lot numbers.
- Contact ConMed immediately if you have affected units.
- Do not use affected devices until you receive further guidance from ConMed or the FDA.
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
71,151 packs (426,908 eaches)
Manufactured in
525 French Rd, Utica, NY, United States
Products
ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 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-2473-2026Want us to check the next one for you?
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