{ "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": 3 } }, "results": [ { "cfres_id": "221199", "product_res_number": "Z-2747-2026", "event_date_initiated": "2026-06-05", "event_date_posted": "2026-07-22", "recall_status": "Open, Classified", "res_event_number": "99290", "product_code": "LRO", "k_numbers": [ "K213481" ], "product_description": "MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G", "code_info": "UDI/DI 10198459280559 (each) 40198459280550 (case), Lot Number 25DBF430", "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 Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.", "root_cause_description": "Under Investigation by firm", "action": "Medline Industries, LP issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/5/2026 via USPS and email. The notice explained the issue, potential risk to health, and requested the following: identify and quarantine product, and complete response and return the response form using the Website link: https://recalls.medline.com. Those who further distributed the affected product have been directed to notify their customers. Upon receipt of the submitted response form, the consignee 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. \nFor questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "60 kits", "distribution_pattern": "US: OH, CA, IL, IN, FL, SC, AZ, NJ.", "openfda": { "k_number": [ "K970187", "K871434", "K890570", "K902887", "K935741", "K935740", "K023276", "K931758", "K980137", "K950574", "K945831", "K872448", "K890726", "K872011", "K914037", "K914036", "K920267", "K932221", "K924468", "K895202", "K931760", "K951149", "K961863", "K920292", "K854292", "K934428", "K874439", "K910365", "K963443", "K913136", "K890729", "K934028", "K854095", "K881083", "K871459", "K871322", "K905004", "K894685", "K935483", "K971061", "K935686", "K041080", "K964921", "K885090", "K213481", "K892389", "K925467", "K944044", "K970286", "K212258", "K963715", "K905459", "K951478", "K931824", "K902293", "K925016", "K922648", "K903336", "K934029", "K961683", "K931844", "K930700", "K871873", "K932652", "K030721", 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