FDA-Device2026-06-24Class IIPROCESSING DEFECT
ConMed AirSeal 12mm Access Port recalled for potential overpressure alerts
What this means
ConMed has recalled certain lots of the AirSeal 12mm Access Port with Palm Grip Obturator (catalog number iAS12-150LPI), a surgical trocar used in laparoscopic procedures. The device may generate overpressure alerts during use, which could affect the surgeon's ability to maintain proper insufflation during surgery.
- If your facility has affected lot numbers (manufactured June 2024–January 2026), stop using them immediately.
- Contact your ConMed representative or check the full recall notice for a complete list of affected lot numbers and instructions.
- Do not use affected units on patients; return them to ConMed or your distributor.
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
3,550 packs (21,300 eaches)
Manufactured in
525 French Rd, Utica, NY, United States
Products
ConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm Length. Catalog Number: iAS12-150LPI. 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-2472-2026Want us to check the next one for you?
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