FDA-Device2026-06-24Class IIPROCESSING DEFECT
ConMed AirSeal 5mm Access Port recalled for potential overpressure alerts
OTHERNationwide distribution
ConMed AirSeal surgical trocar recalled for overpressure alerts
ConMed Corporation has recalled certain lots of the AirSeal 5mm Access Port and Low Profile Obturator (catalog number iAS5-120LP), a disposable surgical trocar used in laparoscopic procedures. The device may generate overpressure alerts during use. This recall affects approximately 196,751 units distributed nationwide and internationally from June 2024 through January 2026.
- Check your device lot number against the FDA recall notice to confirm whether your inventory is affected.
- Contact ConMed Corporation or your medical device supplier for instructions on return or replacement.
- Review the full list of affected lot numbers on the FDA website.
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
32,792 packs (196,751 eaches)
Manufactured in
525 French Rd, Utica, NY, United States
Products
ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS5-120LP. 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-2470-2026More 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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