FDA-Device2026-06-24Class IIPROCESSING DEFECT
ConMed AirSeal 5mm Access Port recalled for potential overpressure alerts during laparoscopy
What this means
ConMed Corporation is recalling certain batches of the AirSeal 5mm Access Port with Low Profile Obturator (catalog number iAS5-100LP), used during laparoscopic surgery to maintain gas pressure in the abdomen. The device may generate overpressure alerts that could affect surgical workflow. No injuries have been reported.
- Check your inventory for lot numbers matching the recall list (manufactured June 14, 2024 to January 12, 2026).
- Stop using affected units and remove them from service.
- Contact ConMed Corporation or your distributor for instructions on replacement or return.
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
36,462 packs (219,850 eaches)
Manufactured in
525 French Rd, Utica, NY, United States
Products
ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 100mm Length. Catalog Number: iAS5-100LP. 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-2471-2026Want us to check the next one for you?
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