{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "187414", "product_res_number": "Z-1841-2021", "event_date_initiated": "2021-04-30", "event_date_created": "2021-06-09", "recall_status": "Open, Classified", "res_event_number": "87910", "product_code": "LRO", "product_description": "Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx.\n\n Convenience kit used to recover tissue, which can be used for medical research, education, or transplantation.", "code_info": "GTIN (01)10193489291186, lot numbers 21CDA959, 21BDB665, 21ADA390, and 20KDC285", "firm_fei_number": "1417592", "recalling_firm": "Medline Industries Inc", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "reason_for_recall": "The devices may not meet the minimum required sterility assurance level.", "root_cause_description": "Software change control", "action": "The recalling firm, Medline Industries, Inc., issued an \"IMMEDIATE ACTION REQUIRED RECALL\" letter dated and emailed on 4/30/2021. The letter described the product, the reason for recall and actions to be taken. The consignees were instructed to immediately check their inventory for the affected product, complete and submit response form online to:\nWebsite link: https://recalls.medline.com; Recall Reference #: R-21-073; \nRecall Code: R5A2C566 , and quarantine it for subsequent return.\n\nIf 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. Have the customers return any affected product to you for collection and return to Medline Industries, Inc.\n\nIf you have any questions, please contact the Recall Department at 866-359-1704.", "product_quantity": "36/3-kit cases (108 kits)", "distribution_pattern": "US Distribution to state of: WI.", "openfda": { "k_number": [ "K882684", "K936117", "K964921", "K872448", "K910368", "K920267", "K931820", "K935686", "K874760", "K842648", "K965201", "K041080", "K952539", "K961683", "K971062", "K903336", "K913136", "K951149", "K854095", "K935743", "K925216", "K962826", "K925016", "K920292", "K963715", "K905004", "K933137", "K944044", "K901856", "K893814", "K923600", "K925467", "K961863", "K871437", "K023276", "K872011", "K924468", "K971061", "K890570", "K950574", "K930270", "K914935", "K902887", "K963443", "K871459", "K945831", "K931824", "K880942", "K945481", "K964011", "K934028", "K931760", "K902293", "K871322", "K930700", "K890726", "K892389", "K873973", "K970286", "K854292", "K932220", 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