FDA-Device2026-06-24Class IIPROCESSING DEFECT
ConMed AirSeal 12mm Access Port recalled for potential overpressure alerts
What this means
ConMed Corporation is recalling certain lots of AirSeal 12mm Access Port and Palm Grip Obturator devices used during laparoscopic surgery. The devices may generate false overpressure alerts that could disrupt surgical procedures.
- Check your inventory against the affected lot numbers listed in the recall notice
- Stop using affected units immediately
- Contact ConMed Corporation for instructions on return or replacement
- Review the FDA recall notice for the complete list of affected lot numbers
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
147,013 packs (882,078 eaches)
Manufactured in
525 French Rd, Utica, NY, United States
Products
ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS12-100LPI. 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-2474-2026Want us to check the next one for you?
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