{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218988", "product_res_number": "Z-1693-2026", "event_date_initiated": "2026-02-18", "event_date_posted": "2026-03-27", "recall_status": "Open, Classified", "res_event_number": "98529", "product_code": "LRO", "product_description": "Sterile Radiology Procedure Kits, Model Number DYNDH1491B", "code_info": "UDI-DI: (CS) 40198459071455,\n(EA) 10198459071454;\nLot Number: 25GBB924", "firm_fei_number": "1417592", "recalling_firm": "Medline Industries, LP", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Haley Barclay\n800-359-1704", "reason_for_recall": "There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility.", "root_cause_description": "Under Investigation by firm", "action": "An URGENT MEDICAL DEVICE RECALL notification letter dated 2/18/26 was sent to customers.\n\nREQUIRED ACTION:\n1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product.\n2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.\nWebsite link: https://recalls.medline.com\nRecall Reference #: R-26-015-FG\nRecall Code: \n3. Your account will receive credit once the response form is submitted.\n4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form.\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "420 units", "distribution_pattern": "US Nationwide distribution in the state of MN.", "openfda": { "k_number": [ "K854095", "K903336", "K936117", "K880942", "K931759", "K874439", "K925216", "K934030", "K023276", "K890098", "K924468", "K945481", "K882684", "K880961", "K920267", "K935858", "K913136", "K932217", "K963443", "K953083", "K910365", "K872448", "K905459", "K041080", "K895202", "K934029", "K951478", "K935686", "K212258", "K951149", "K930270", "K934688", "K925467", "K910368", "K923600", "K970187", "K871459", "K961683", "K842648", "K930700", "K871437", "K871434", "K922648", "K964921", "K935740", "K914037", "K934028", "K890658", "K885090", "K945160", "K914036", "K941846", "K971061", "K970286", "K965201", "K931760", "K961863", "K944044", "K971062", "K902888", "K871873", "K890570", "K964011", 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"2" } } ] }