FDA-Device2026-06-24Class IIPROCESSING DEFECT
ConMed AirSeal 8mm Access Port recalled for potential overpressure alerts
OTHERNationwide distribution
ConMed AirSeal trocar recalled for overpressure alerts
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.
Hazard
Potential for overpressure alerts.
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-2467-2026More ConMed Corporation recalls
- FDA-Device2026-06-24ConMed AirSeal 5mm Access Port recalled for potential overpressure alerts during laparoscopy
- FDA-Device2026-06-24ConMed AirSeal 12mm Access Port recalled for overpressure alert malfunction
- FDA-Device2026-06-24ConMed AirSeal 12mm Access Port recalled for overpressure alert risk
- FDA-Device2026-06-24ConMed AirSeal 5mm Access Port recalled for potential overpressure alerts
- FDA-Device2026-06-24ConMed AirSeal 8mm Access Port recalled for potential overpressure alerts
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