FDA-Device2026-06-24Class IIPROCESSING DEFECT
ConMed AirSeal 12 mm Access Port recalled for overpressure alert malfunction
What this means
ConMed Corporation is recalling certain AirSeal 12 mm Access Port and Obturator units (catalog iASB12-120) used in laparoscopic surgery because they may fail to generate proper overpressure alerts. This could allow pressure levels to rise unexpectedly during procedures. The affected units were manufactured between June 2024 and January 2026.
- Check your inventory for catalog number iASB12-120 and the affected lot numbers listed in this recall.
- Stop using affected units immediately and do not use them for procedures.
- Contact ConMed Corporation or your equipment supplier for instructions on returning or replacing affected devices.
- Notify your surgical team and facility leadership of this 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
891 packs (5,346 eaches)
Manufactured in
525 French Rd, Utica, NY, United States
Products
ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 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-2465-2026Want us to check the next one for you?
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