{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216093", "product_res_number": "Z-0150-2026", "event_date_initiated": "2025-09-09", "event_date_posted": "2025-10-14", "recall_status": "Open, Classified", "res_event_number": "97605", "product_code": "KWY", "k_numbers": [ "K100761" ], "product_description": "BioPro Bipolar Head\n\nProduct ID/Description\n18130\tBIPOLAR HEAD 38MM\n18131\tBIPOLAR HEAD 39MM\n18132\tBIPOLAR HEAD 40MM\n18133\tBIPOLAR HEAD 41MM\n18134\tBIPOLAR HEAD 42MM\n18135\tBIPOLAR HEAD 43MM\n18136\tBIPOLAR HEAD 44MM\n18137\tBIPOLAR HEAD 45MM\n18138\tBIPOLAR HEAD 46MM\n18139\tBIPOLAR HEAD 47MM\n18140\tBIPOLAR HEAD 48MM\n18141\tBIPOLAR HEAD 49MM\n18142\tBIPOLAR HEAD 50MM\n18143\tBIPOLAR HEAD 51MM\n18144\tBIPOLAR HEAD 52MM\n18145\tBIPOLAR HEAD 53MM\n18146\tBIPOLAR HEAD 54MM\n18147\tBIPOLAR HEAD 55MM\n18148\tBIPOLAR HEAD 56MM\n18149\tBIPOLAR HEAD 57MM\n18150\tBIPOLAR HEAD 58MM\n18151\tBIPOLAR HEAD 59MM\n18152\tBIPOLAR HEAD 60MM", "code_info": "Product ID/UDI-DI\n\n18130\tM20918130\n18131\tM20918131\n18132\tM20918132\n18133\tM20918133\n18134\tM20918134\n18135\tM20918135\n18136\tM20918136\n18137\tM20918137\n18138\tM20918138\n18139\tM20918139\n18140\tM20918140\n18141\tM20918141\n18142\tM20918142\n18143\tM20918143\n18144\tM20918144\n18145\tM20918145\n18146\tM20918146\n18147\tM20918147\n18148\tM20918148\n18149\tM20918149\n18150\tM20918150\n18151\tM20918151\n18152\tM20918152\n\nAll lots, all serial numbers", "firm_fei_number": "1832656", "recalling_firm": "BioPro, Inc.", "address_1": "2929 Lapeer Rd", "city": "Port Huron", "state": "MI", "postal_code": "48060-2558", "additional_info_contact": "Mr. Patrick Pringle\n810-982-7777", "reason_for_recall": "Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.", "root_cause_description": "Package design/selection", "action": "Consignees were notified on September 9, 2025, via phone, followed by formal letters with instructions for returning the inventory to BioPro.", "product_quantity": "147 total", "distribution_pattern": "US Domestic distribution to Texas and Michigan.", "openfda": { "k_number": [ "K220492", "K945518", "K100151", "K183114", "K925420", "K904383", "K223441", "K961793", "K934159", "K862057", "K132539", "K940743", "K862460", "K931655", "K192236", "K152439", "K896257", "K981238", "K082468", "K050966", "K970284", "K963885", "K953977", "K982447", "K926387", "K884658", "K913632", "K062693", "K003363", "K881289", "K170072", "K131354", "K060707", "K173455", "K823726", "K855231", "K100761", "K810062", "K101670", "K023743", "K013211", "K900051", "K050269", "K091967", "K080647", "K010081", "K014072", "K781735", 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