{ "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": "219610", "product_res_number": "Z-2138-2026", "event_date_initiated": "2026-03-24", "event_date_posted": "2026-05-08", "recall_status": "Open, Classified", "res_event_number": "98735", "product_code": "DTL", "k_numbers": [ "K782095" ], "product_description": "Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.", "code_info": "UDI/DI each 10193489059144, UDI/Di case 30193489059148, Lot Numbers: 90184, 94779, 97786, 106351, 108597, 109876, 114056, 114989, 115459, 115931, 116358, 116865, 118245, 122974, 126077, 127795, 129531, 130557, 136114, 150501, 151591, 152772, 154514, 156045, 160318, 163255, 168053.", "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\n866-359-1704", "reason_for_recall": "Medline has identified the presence of particulate within the fluid path of the Manifolds.", "root_cause_description": "Under Investigation by firm", "action": "Medline Industries, LP issued an URGENT MEDICAL DEVICE notice to its consignees on 3/24/2026 via email and mail. The notice explained the issue, potential risk and requested the following:\n\"REQUIRED 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-26-046\nRecall Code: \n3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.\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 include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product.\"\nFor questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "7075 units", "distribution_pattern": "US (nationwide) and AE, AU, CA, JP, KR, NL, SG, SK.", "openfda": { "k_number": [ "K120069", "K933084", "K913363", "K031688", "K030077", "K080472", "K851465", "K831260", "K790564", "K952531", "K911884", "K913161", "K123448", "K760843", "K041697", "K925419", "K073474", "K122301", "K842829", "K893683", "K942391", "K945461", "K040498", "K812407", "K853749", "K113667", "K961181", "K880831", "K072745", "K820297", "K092711", "K100319", "K092563", "K993057", "K113845", "K782095", "K122811", "K892368", "K897197", "K101113", "K891572", "K854261", "K801828", "K021282", "K873971", "K861783", "K812408", "K072556", "K862451", "K897137", "K791914", "K813141", "K951089", "K791107", "K953564", "K852118", "K914987", 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} ] }