FDA DevicesClass II
ConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Cat...
Published: June 24, 2026Recall ID: Z-2465-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for overpressure alerts.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Utica |
| State | NY |
| Event id | 98854 |
| Address 1 | 525 French Rd |
| Code info | 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. |
| Postal code | 13502-5945 |
| Report date | 20260624 |
| Product type | Devices |
| Product quantity | 891 packs (5,346 eaches) |
| Reason for recall | Potential for overpressure alerts. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260514 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260617 |
Overview
- Recalling FirmConMed Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide 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. .