{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "221496", "product_res_number": "Z-2991-2026", "event_date_initiated": "2026-07-13", "event_date_posted": "2026-08-21", "recall_status": "Open, Classified", "res_event_number": "99403", "product_code": "BTT", "k_numbers": [ "K031383" ], "product_description": "Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit", "code_info": "All lot codes", "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": "Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.", "root_cause_description": "Under Investigation by firm", "action": "Medline issued an Urgent Medical Device notice it its consignees on 7/13/2026 via email and USPS. The notice explained the issue, potential risk, and provided actions and precautions for healthcare providers.\n\nIf evidence of connector overheating or thermal damage is observed:\n\"\tAssess the patient and ensure continued respiratory support.\n\"\tReplace the affected circuit as soon as clinically appropriate.\n\"\tRemove the affected circuit from service and retain it for investigation.\" \n\nFor questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. \n\nFollow up notice sent on 7/27/2026 to clarify the item numbers. \n\n***\n\nUpdated customer communication was sent out on 8/5/26. Consignees were instructed to destroy affected inventory. The firm has begun distributing corrected product.", "product_quantity": "20 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Panama.", "openfda": { "k_number": [ "K893122", "K780562", "K920306", "K132017", "K790731", "K874659", "K072982", "K873472", "K971260", "K914686", "K831163", "K233821", "K842794", "K913368", "K002454", "K800056", "K001213", "K063758", "K222292", "K911770", "K013486", "K945782", "K851879", "K923946", "K121975", "K802852", "K163283", "K810559", "K901762", "K191818", "K831556", "K132857", "K102618", "K880702", "K133766", "K070714", "K760584", "K010578", "K253479", "K950582", "K050314", "K850647", "K770415", "K791683", "K220703", "K823143", "K872139", "K222351", "K090915", "K231956", "K162242", "K230559", "K863955", "K760938", "K781468", "K080797", "K900569", "K896315", "K991484", "K031176", "K203357", "K180474", "K041963", "K936000", "K894000", "K031179", "K802145", "K832928", "K070107", "K000401", "K760923", "K140556", 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"3008264065", "3042226221", "3030733800", "3030089838", "3003799815", "1000115734", "3006636961", "3042507287", "1417592", "3005587132", "1417519", "3016723884", "3011971979", "3000215273", "3001237338", "3000126629", "3043709870", "3012316249", "2024500", "3016052406", "3029706818", "3030446844", "3014499739", "3004604967", "3009129579", "3021947238", "3030308442", "3006363476", "2523148", "3002807267", "3005440755", "3048101987", "3006606984", "3004365956", "3011120183", "3016450067", "3002806988", "3003949221", "3001421318", "2025816", "3013517171", "3002808696", "3018094310", "3003135857" ], "device_name": "Humidifier, Respiratory Gas, (Direct Patient Interface)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5450", "device_class": "2" } } ] }