{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "199285", "product_res_number": "Z-1558-2023", "event_date_initiated": "2023-03-09", "event_date_posted": "2023-05-04", "recall_status": "Open, Classified", "res_event_number": "91804", "product_code": "CAW", "k_numbers": [ "K071397" ], "product_description": "DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR", "code_info": "Model 1025DS - UDI-DI: 00885304000846;\nSerial Numbers A175230001DS to A232160185DS;\n\nModel 1025UK - UDI-DI: 00885304022480;\nSerial Numbers A179210001US to A232060432US;\n\nModel 1025KS - UDI-DI: 00853040224734;\nSerial Numbers A176060001KS to A232220085KS;\n\nModel 1025KS-AR - UDI-DI: 00853040224734;\nSerial Numbers A216240003KS to A229210010KR", "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\n989-989-5190", "reason_for_recall": "The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard.", "root_cause_description": "Labeling design", "action": "An URGENT NOTICE MEDICAL DEVICE CORRECTION notification dated 3/9/23 was sent to customers.\n\nActions to be Taken by Our Customers\nPlease immediately click on the hyperlinked Verification Code at the top of this Notice to go to our dedicated instruction manual update website, www.recallrtr.com/1025series (or access the website manually), and follow the simple process set up to:\n Download electronic copies, or order hard copies, of the updated instruction manual.\n Download a spreadsheet containing the serial numbers of all affected units sold to your\ncompany.\n Replace the instruction manual for any units in your possession, and distribute the updated instruction manual to your customers, and\n Submit an Acknowledgement Form confirming the number of instruction manuals you replaced and distributed to customers to replace.\nShould you need further assistance, we have also set up a dedicated call center, which can be reached at 1 (833) 820-0836, from 8:00 am to 7:00 pm EST Monday through Friday.", "product_quantity": "143,397 units", "distribution_pattern": "Worldwide - US Nationwide distribution.", "openfda": { "k_number": [ "K812282", "K134023", "K933081", "K873071", "K884581", "K260171", "K072688", "K760704", "K222920", "K253549", "K971129", "K844328", "K842114", "K843715", "K771665", "K982243", "K120785", "K851434", "K102245", "K100920", "K162433", "K991569", "K851438", "K242736", "K131990", "K983777", "K252965", "K993088", "K230052", "K904087", "K831819", "K942357", 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