{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196759", "product_res_number": "Z-0724-2023", "event_date_initiated": "2022-11-18", "event_date_posted": "2022-12-19", "recall_status": "Open, Classified", "res_event_number": "91112", "product_code": "CAW", "k_numbers": [ "K071397" ], "product_description": "DeVilbiss, 525 5-liter Oxygen Concentrator\nModels 525DS, 525DS-Q", "code_info": "Model 525DS\nUDI-DI 00885304000846\nAll Lots\n\nModel 525DS-Q\nUDI-DI 00885304009689\nAll Lots", "firm_fei_number": "2515872", "recalling_firm": "DeVilbiss Healthcare LLC", "address_1": "100 Devilbiss Dr", "city": "Somerset", "state": "PA", "postal_code": "15501-2125", "additional_info_contact": "Roberto Munoz\n800-338-1988", "reason_for_recall": "The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.", "root_cause_description": "Labeling False and Misleading", "action": "On November 18, 2022, the firm notified customers through Urgent Notice Medical Device Correction letters/emails. \n\nThe firm is updating its instruction manual to include the following:\n\n\" warnings related to applied parts that may come into contact with a patient that, when under single fault failure conditions while operating at maximum environmental temperatures, could cause the surface temperature of the part to exceed 41C;\n\" clarifications regarding the expected service life for the unit; and\n\" additional instructions regarding wear components that may require maintenance during the expected service life of the product.\n\nCustomers may navigate to www.recallrtr.com/525series to obtain copies of the updated instruction manual.\n\nThe firm may be reached at 1 (833) 408-0512, from 8:00 am to 7:00 pm EST Monday through Friday.", "product_quantity": "1004315 (US); 414559 (OUS)", "distribution_pattern": "US Nationwide. Foreign distribution pending.", "openfda": { "k_number": [ "K884018", "K971889", "K040738", "K081206", "K141967", "K791437", "K955549", "K213210", "K895141", "K100957", "K093308", "K012037", "K935370", "K780862", "K080082", "K903608", "K844312", "K843243", "K851439", "K802426", "K072688", "K851434", "K073242", "K811155", "K252407", "K823524", "K011844", "K191159", "K851435", "K884563", "K924565", "K844328", "K843691", "K192693", "K132489", "K851438", "K813320", "K021685", "K020330", "K791043", "K123738", "K942357", "K822871", "K913327", "K061261", "K983627", "K080391", "K790520", "K060922", "K954506", "K942082", "K083163", "K873526", "K822301", "K861011", "K041664", "K100920", "K003939", "K971964", "K030233", "K830174", "K904639", "K150930", "K971129", "K091716", "K013931", "K983777", "K830046", "K252616", "K850253", "K083559", "K240561", "K803232", "K801104", "K854374", "K864045", "K191875", "K771761", "K924152", "K253549", "K013223", "K251764", "K981078", "K891488", "K014078", 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"3015772781", "2515872", "1924066", "3000126629", "1039215", "3007220521", "3011191255", "1000374126", "2518422", "3002768081", "3043648593", "3025889185", "3005803793", "3017825461", "1000604079", "3018783526", "1000115734", "3023245116", "3017520736", "3007740533", "3002807637", "3007344957", "3000210616", "3008910673", "3006277965", "3006240053", "3016809216", "3003207908", "3037045878", "3012316249", "3011767915", "3003949221", "3045816954", "3011895992", "3027241818", "1419185", "3020476987", "3013000203", "3027605507", "3009550619", "3001400310", "3010440667", "3003637574", "3014661487", "3007307467", "3014810929" ], "device_name": "Generator, Oxygen, Portable", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5440", "device_class": "2" } } ] }