{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 11 } }, "results": [ { "cfres_id": "219998", "product_res_number": "Z-2464-2026", "event_date_initiated": "2026-05-14", "event_date_posted": "2026-06-17", "recall_status": "Open, Classified", "res_event_number": "98854", "product_code": "HIF", "k_numbers": [ "K143404" ], "product_description": "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", "code_info": "Catalog Number: iASB5-150. UDI-DI: 10845854045695. Lot Numbers: 202510144, 202508124, 202501144, 202408144, 202412044, 202505064, 202511284. \n\n*OUS added 06/10/2026 expansion: 202408144, 202501144, 202505064, 202508124, 202510144. \n\nManufactured from 14 June 2024 to 12 January 2026.", "firm_fei_number": "3001451571", "recalling_firm": "ConMed Corporation", "address_1": "525 French Rd", "city": "Utica", "state": "NY", "postal_code": "13502-5945", "reason_for_recall": "Potential for overpressure alerts.", "root_cause_description": "Process change control", "action": "ConMed notified consignees on about 05/14/2026 via emailed and mailed letter titled URGENT: Medical Device Correction. Consignees were made aware of the issue and risk associated with the issue. They were instructed that a replacement AirSeal disposable should be available prior to procedures in order to minimize potential delays. Before initiating insufflation, the user should ensure the tubing is properly connected between the AirSeal tube set and Airseal Access Ports. If the connection cannot be securely tightened and the overpressure alert cannot be resolved, please replace the affected device. Detailed instructions were provided on how to connect the AirSeal tube set and Airseal Access Ports. \n\nConsignees were also instructed to review inventory for affected units, place a copy of the provided Instructions for Use, Part No. AS-DIS-IFU, Rev. B with any inventory in possession with an active expiration date, contact all applicable departments and facilities that may have received affected products for awareness, and complete and return the medical device response form. If further information relevant to this issue becomes necessary CONMED will communicate as such.\n\nOn about 06/04/2026 ConMed expanded their recall to include internationally distributed units. The letter sent included the same instructions.", "product_quantity": "497 packs (2,982 eaches)", "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.\n.", "openfda": { "k_number": [ "K221995", "K201361", "K900878", "K211104", "K150068", "K921264", "K073452", "K162582", "K121336", "K001068", "K091366", "K090456", "K993625", "K921756", "K111955", "K951961", "K022052", "K934131", "K943954", "K905417", "K935862", "K914153", "K945789", "K922777", "K112357", "K172835", "K922245", "K925691", "K915694", 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