ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Lengt...
FDA Device Recall #Z-2473-2026 - Class II, May 14, 2026
Recall Summary
| Recall Number | Z-2473-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | May 14, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ConMed Corporation |
| Location | Utica, NY |
| Product Type | Devices |
| Quantity | 71,151 packs (426,908 eaches) |
Product Description
ConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 120mm Length. Catalog Number: iAS12-120LPI. 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. .
Lot / Code Information
Catalog Number: iAS12-120LPI. UDI-DI: 10845854045688. Lot Numbers: 202506164, 202507144, 202506274, 202506136, 202506124, 2025071010, 202507114, 202506244, 202505194, 202505164, 202505064, 202505144, 202509114, 202508204, 202509124, 202510184, 202509274, 202511064, 202509254, 202509264, 202510254, 202510274, 202508294, 202509104, 202508214, 202509154, 202508084, 202507264, 202507254, 2025080611, 202507284, 202512124, 202511204, 202511214, 202511244, 202512134, 2025100310, 202510034, 202510154, 202511065, 202511075, 202511074, 202510244, 202510174, 202502214, 202503204, 202503075, 202503064, 202504244, 202504025, 2025040310, 2025040411, 202504046, 202503215, 202503244, 202504044, 202501164, 202501244, 202501235, 202506134, 202406204, 202406245, 202408154, 202502194, 202501145, 202505054, 202504036, 202412134, 202501274, 202408095, 202407316, 202410305, 202410244, 202506254, 202508274, 202509244, 202410234, 202411045, 202409035, 202407106, 202506304, 202512104, 202510204, 202501225, 202406214, 2025040210, 2025042110, 2025080810, 202508264, 202408135, 202410315, 202410295, 202408214, 202408294, 202507234, 202505304, 202505294, 202407155, 202408204, 202408206, 202406195, 202503065, 202502244, 202501095, 202504305, 202511086, 2024111911, 202501144, 2025110410, 2025110510, 202510164, 202511104, 2025122310, 202504304, 202501166, 202502184, 202407104, 202406215, 202406206, 202506264, 202410255, 202508284, 202507244, 202408015, 202505154, 202407305, 202411236, 2024112210, 202412105, 2025110512, 202501224, 202512154, 202407114, 202504294, 2025111910, 202407105, 202406266, 202501104, 202501275, 202503086, 2025040211, 2025111810, 2025041610, 2025110511, 202411054, 202408164, 202507104, 202408065, 202501286, 202503114, 202503214, 202412235, 202506024, 2024112111, 2024112010, 202505274, 202410304, 202411015, 202410225, 202408125, 202408205, 202409034, 202408165, 202510035, 202408155, 202408296, 202407154, 202407124, 202408064, 202406284, 202406205, 202601064, 2025122210, 2025111410, 202511066, 202411265, 202411225, 202411224, 202506104, 202408176, 202410294, 202512234, 202407015, 202407014, 202407125, 202504224, 202505014, 202411195, 202502064, 202411014, 202408094, 202411216, 202411214, 202504214, 202507094, 202406285, 202406244, 202502205, 202503205, 2024112610, 202412144, 202410235, 202411255, 202501246, 202408106, 202408224, 202407254, 202407024, 202504056, 202503245, 202501245, 202502075, 202501234, 202502114, 2024112011, 202411206, 202412135, 202406275, 202501024, 202411276, 202412124, 2024112211, 2024121210, 2025102310, 202512114, 202601055, 2025080710, 202506114, 202505284, 202505176, 202407314, 202408144, 202408134, 202410245, 202411194, 202411254, 2024121310, 202501025, 202501155, 202412114, 202408084, 202501086, 202502204, 202501034, 202412226, 202406254, 202509014, 2025100210, 202511076, 202503195, 202412164, 202407256, 202407116, 202411226, 202406286, 202407136, 202408194, 2025081110, 202411205, 202408146, 202411264, 202412234, 202411215, 202406226, 2025040710, 202501256, 202502055, 202410314, 202410284, 202408295, 202408145, 202408136, 202501154, 202502105, 202501236, 202411266, 202408124, 2024121311, 202503105, 2025040311, 202406255, 202407095, 202412125, 2024112510, 2025043010, 2024112110, 2024112511, 202408156, 202501226, 202408216, 202501085, 202407026, 2026010511, 2024071212, 202407126, 202410285, 202408166, 202406256, 202504174, 2024121211. *OUS added 06/10/2026 expansion: 202411204, 202511075, 202511244, 202509154, 202509104, 202509264, 202508084, 2025080611, 202507284, 202507254, 202507264, 202504174, 202506274, 2025040310, 202504244, 202505144, 202501085, 202501094, 202504164, 202502214, 2024112110, 202410245, 202410285, 202411044, 2024112011, 202412105, 202411266, 202510274, 202510184, 202406226, 202406216, 202407024, 202407136, 202408066, 2024071212, 202511064, 202511065, 202509274, 202508214, 202510254, 202506124, 202503204, 202504044, 202505064, 202503075, 202501244, 202501154, 202407026, 202408194, 202407116, 202511214, 2025071010, 202505164, 202410315, 202501166, 202512124, 202408304, 202410225, 202408135, 202511074, 202509124, 202510244, 2025100310, 202507144, 202505194, 2025041710, 202501084, 202406255, 202407126, 202408195, 202411214, 202408084, 202508204, 2025040410, 202411225, 202509114, 202503064, 202406256, 202407245, 202412124, 202511204, 202509254, 202510154, 202510034, 202504046, 2025040411, 202501235, 202501256, 202510035, 202512154, 202503065, 202407105, 202408144, 202506114, 202510204, 202512114, 202503245, 202501034, 202501224, 202411215, 202507244, 202509014, 202509244, 202508284, 202511086, 202511104, 202601064, 2024121210, 202408216, 202412234, 202502114, 202504056, 202411194, 2025043010, 202506134, 202507114, 202406245, 202408164, 2025080810, 202409034, 202508264, 202406214, 202408295, 202410294, 202504304, 202506164, 202506304, 202502105, 2024121311, 202410305, 202408146, 202504214, 202501164, 202601124, 202507234, 2025041610, 202501145, 202410284, 202408064, 202408136, 202406204, 202501024, 202501025, 2024121310, 202505284, 202501234, 202411195, 202411205, 202408166, 202408176, 202505054, 202410295, 202408155, 202407154, 202407114, 202407125, 202508294, 2025110512, 202507104, 2025042110, 202502075, 202506024, 202501245, 202410304, 202410314, 2024112210, 202512234, 202505014, 202510164, 202406254, 202505304, 202502055, 2025110510, 202506136, 202506244, 202408156, 202508274, 202506254, 202504224, 202501236, 2024112211, 202408124, 202503215, 202501286, 202412144, 2024112511, 202408145, 202408065, 202501226, 202412125, 2025110410, 202510174, 202504025, 202503244, 202504036, 2025040210, 202408165. Manufactured from 14 June 2024 to 12 January 2026.
Other Recalls from ConMed Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-3018-2026 | Class II | CONMED Linvatec GENESYS CrossFT Suture Anchor w... | Jul 14, 2026 |
| Z-2468-2026 | Class II | ConMed AirSeal 8mm Access Port and Low Profile ... | May 14, 2026 |
| Z-2467-2026 | Class II | ConMed AirSeal 8mm Access Port and Low Profile ... | May 14, 2026 |
| Z-2466-2026 | Class II | ConMed AirSeal 12mm Access Port and Obturator w... | May 14, 2026 |
| Z-2471-2026 | Class II | ConMed AirSeal 5mm Access Port and Low Profile ... | May 14, 2026 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.