{ "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": 1 } }, "results": [ { "cfres_id": "220593", "product_res_number": "Z-2794-2026", "event_date_initiated": "2026-05-21", "event_date_posted": "2026-07-23", "recall_status": "Open, Classified", "res_event_number": "99027", "product_code": "HIH", "k_numbers": [ "K961605" ], "product_description": "Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.", "code_info": "Kit UDI-DI: 04048551226087. Kit Serial Numbers: 2274269, 2273282, 2276217, 2276216, 2264656, 2275787, 2279756, 2280154, 2280379, 2275789, 2283453, 2277877, 2280204, 2273324, 2275986, 2283483, 2229591, 2273599, 2215800, 2274197, 2280156, 2275483, 2083136, 2275790, 2275482, 2274271, 2248338, 2283444, 2188673, 2276221, 2276217, 2275788, 2274199, 2283445, 2274198, 2274041, 2283716, 2274049, 2236228, 2279757, 2274267, 2275785, 2277894, 2230599, 2267785.\n\n26153EAU/1 seals with expiration date: January 23, 2023.", "firm_fei_number": "3007475226", "recalling_firm": "Karl Storz Endoscopy", "address_1": "2151 E Grand Ave", "city": "El Segundo", "state": "CA", "postal_code": "90245-5017", "additional_info_contact": "Kathy Strange\n774-284-1736", "reason_for_recall": "Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.", "root_cause_description": "Packaging change control", "action": "On 5/21/2026, correction notices were emailed to customers who were asked to do the following:\n1) Check the expiration date for any inventory of 26153EAU-01 Sealing Seal for Gynecology and discard any expired components(seals) by removing the seal from the packaging and discarding the seal and packaging.\n2) Pass on this Urgent Medical Device Correction to all users of affected products and all other persons who need to be aware within your organization.\n3) If you have or may have distributed the products listed, please identify and\npromptly notify those recipients with a copy of this notice and response form.\n4) Completed and return the Customer Reply Form via email to KSEAProductLabeling@karlstorz.com\n\nFor all other questions regarding this communication, please send an email to\nKSEAProductLabeling@karlstorz.com.", "product_quantity": "45", "distribution_pattern": "US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, 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