Z-2469-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 24, 2026
- Initiation Date
- May 14, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,668 packs (10,005 eaches)
Product Description
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.
Reason for Recall
Potential for overpressure alerts.
Distribution Pattern
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. .
Code Information
Catalog Number: iAS5-75LP. UDI-DI: 10845854046388. Lot Numbers: 202509294, 202508044, 202505144, 202504014, 202502275, 202512034, 202507014, 202510084, 202412144, 202411065, 202409305, 202406284, 202408014, 202409304, 202506254. *OUS added 06/10/2026 expansion: 202502275, 202509294, 202504014, 202507014, 202505144, 202512034, 202411065, 202508044, 202409305, 202409304, 202408014, 202506254, 202510084, 202412144, 202406284. Manufactured from 14 June 2024 to 12 January 2026.