{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "193498", "product_res_number": "Z-1369-2022", "event_date_initiated": "2022-06-10", "event_date_created": "2022-07-12", "recall_status": "Open, Classified", "res_event_number": "90108", "product_code": "CAW", "k_numbers": [ "K203210" ], "product_description": "Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)", "code_info": "UDI-DI: 00841447112075  Serial Number Prefixes:  21FEXXXXXX\t21JEXXXXXX 21GEXXXXXX\t21KEXXXXXX 21HEXXXXXX\t21LEXXXXXX 21IEXXXXXX", "firm_fei_number": "1525712", "recalling_firm": "Invacare Corporation", "address_1": "1200 Taylor St", "city": "Elyria", "state": "OH", "postal_code": "44035-6248", "additional_info_contact": "Invacare Corporation\n877-413-6008", "reason_for_recall": "Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the \"Rx Only\" statement as required.", "root_cause_description": "Labeling Change Control", "action": "On June 10, 2022, the firm distributed Medical Device Correction letters to affected providers. Providers were informed that they may have received product with an incorrect label which does not contain the required \"Rx Only\" symbol. Providers were provided with Provider Acknowledgement Cards which included instructions for applying the correct product label to the device. Providers are responsible for ensuring that the field correction is conducted with their customers. \n\nIf you have any questions concerning these instructions, please call Invacare's field correction support line at (877) 413-6008 (U.S. Customers) Monday thru Friday, 8 a.m. 5 p.m. EST, for assistance.", "product_quantity": "179 devices", "distribution_pattern": "Domestic distribution to the following states: ALASKA\nARIZONA\nCALIFORNIA\nCOLORADO\nGEORGIA\nIDAHO\nIOWA\nKANSAS\nKENTUCKY\nMICHIGAN\nMINNESOTA\nMISSOURI\nNEW YORK\nNORTH CAROLINA\nOHIO\nOKLAHOMA\nPENNSYLVANIA\nTENNESSEE", "openfda": { "k_number": [ "K083163", "K131990", "K213825", "K833500", "K082566", "K843811", "K822889", "K781300", "K020362", "K813018", "K050430", "K071608", "K091650", "K842753", "K251607", "K860060", "K761213", "K020386", "K242736", "K883837", "K061261", "K192693", "K061414", "K071461", "K053240", "K895141", "K941145", "K993088", "K952037", "K813320", "K854509", "K924818", "K873156", "K851435", 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