FDA Medical devices recall ·
ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length recall
- Recall number
- Z-2465-2026
- Date
- (initiated May 14, 2026)
- Company / brand
- ConMed Corporation
525 French Rd, Utica, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 891 packs (5,346 eaches)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog Number: iASB12-120. 6 units per pack. Disposable Endoscopic Trocar and Cannula; Carbon Dioxide Insufflator for Laparoscopy.
Why was it recalled?
Potential for overpressure alerts.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: iASB12-120. UDI-DI: 10845854045725. Lot Numbers: 202507314, 202506194, 202510024, 202501165, 202504034, 202408225, 202411264. *OUS added 06/10/2026 expansion: 202510024, 202507314, 202504034, 202501165, 202411264, 202408225, 202506194. Manufactured from 14 June 2024 to 12 January 2026.
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. .
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2465-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.