FDA-Device2026-06-24Class IIPROCESSING DEFECT
ConMed AirSeal 5mm Access Port recalled for potential overpressure alerts
OTHERNationwide distribution
ConMed AirSeal trocar recalled for overpressure alert risk
ConMed Corporation is recalling certain AirSeal 5mm Smooth Access Ports (Catalog Number iASB5-150) used in laparoscopic surgery. The device may generate overpressure alerts during use, which could affect surgical workflow or require device replacement during a procedure.
- Stop using affected units immediately if you have them in stock.
- Check if your inventory includes Catalog Number iASB5-150 with lot numbers 202510144, 202508124, 202501144, 202408144, 202412044, 202505064, or 202511284.
- Contact your ConMed representative or the FDA for instructions on return or replacement.
- Review any procedures performed with affected units and monitor patients for any complications.
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
497 packs (2,982 eaches)
Manufactured in
525 French Rd, Utica, NY, United States
Products
ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length. Catalog Number: iASB5-150. 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-2464-2026More 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 8mm Access Port recalled for potential overpressure alerts
- FDA-Device2026-06-24ConMed AirSeal 8mm Access Port recalled for potential overpressure alerts
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