FDA-Device2026-06-24Class IIPROCESSING DEFECT
ConMed AirSeal 5mm Access Port recalled for overpressure alert risk
What this means
ConMed has recalled certain lots of the AirSeal 5mm Access Port with Low Profile Obturator, a surgical instrument used in laparoscopic procedures. The device may generate overpressure alerts that could affect proper operation during surgery.
- Check your inventory for catalog number iAS5-75LP manufactured between June 14, 2024 and January 12, 2026.
- Verify lot numbers against the recalled list (includes 202509294, 202508044, 202505144, and others listed by FDA).
- Contact ConMed for instructions on how to handle affected units.
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
1,668 packs (10,005 eaches)
Manufactured in
525 French Rd, Utica, NY, United States
Products
ConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm Length. Catalog Number: iAS5-75LP. 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-2469-2026Want us to check the next one for you?
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