FDAFDA recall Z-2464-2026 · Jun 24, 2026
ConMed Corporation: ConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip recall
Recall found
Product
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
Reason for recall
Potential for overpressure alerts.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Catalog Number: iASB5-150. UDI-DI: 10845854045695. Lot Numbers: 202510144, 202508124, 202501144, 202408144, 202412044, 202505064, 202511284. *OUS added 06/10/2026 expansion: 202408144, 202501144, 202505064, 202508124, 202510144. Manufactured from 14 June 2024 to 12 January 2026.
- Quantity
- 497 packs (2,982 eaches)
- Distribution
- 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. .
- Recalling firm
- ConMed Corporation, Utica, NY
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-14
Source: openFDA enforcement record Z-2464-2026 · search recall number Z-2464-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.