{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218028", "product_res_number": "Z-1498-2026", "event_date_initiated": "2026-01-05", "event_date_posted": "2026-03-06", "recall_status": "Open, Classified", "res_event_number": "98254", "product_code": "INN", "product_description": "Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300\nUDI-DI code: (01)00628758003007\n\nRaz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333\nUDI-DI code: (01)00628758003335\n\nRaz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360\nUDI-DI code: (01)00628758003601\n\nRaz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200\nUDI-DI code: (01)00628758001003\n\nRaz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100\nUDI-DI code: (01)00628758001003\n\nThe Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene.", "code_info": "Raz-AT (Attendant Tilt) Mobile Shower Commode Chair\nCatalog Number Z300\nSeat Catalog Numbers:\nZVFIFAR17\nZVFIFAR20\nZCSEAT (FAR)\nUDI-DI code: (01)00628758003007\nSerial Numbers:\nRAT218789\nRAT116906\nRAT200337\nRAT208010\nRAT208987\nRAT210426\nRAT211344\nRAT211837\nRAT211998\nRAT212001\nRAT212066\nRAT212450\nRAT213190\nRAT213227\nRAT214334\nRAT217987\nRAT218213\nRAT218552\nRAT218570\nRAT218612\nRAT219142\nRAT220066\nRAT222210\nRAT223140\nRAT224902\nRAT206923\nRAT217768\nRAT221724\nRAT213036\nRAT218862\nRAT221044\nRAT216437\nRAT217073\nRAT218555\nRAT218557\nRAT219817\nRAT121348\nRAT216055\nRAT217379\nRAT220648\nRAT124264\nRAT200864\n\nRaz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair\nCatalog Number Z333\nSeat Catalog Numbers:\nZVFIFAR17\nZVFIFAR20\nZCSEAT (FAR)\nUDI-DI code: (01)00628758003335\nSerial Numbers:\nART219556\nART222544\nART211605\nART223825\nART212722\nART212675\n\nRaz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair\nCatalog Number Z360\nSeat Catalog Numbers:\nZCSEATHD (FAR)\nUDI-DI code: (01)00628758003601\nSerial Numbers:\nBAT216618\nBAT204112\n\nRaz-SP (Self Propel) Mobile Shower Commode Chair\nCatalog Number Z200\nSeat Catalog Numbers:\nZVFIFAR17\nZVFIFAR20\nZCSEAT (FAR)\nUDI-DI code: (01)00628758001003\nSerial Numbers:\nRAS210872\nRAS214903\nRAS217818\nRAS220760\nRAS209166\nRAS218239\nRAS107030\nRAS214470\n\nRaz-AP (Attendant Propel) Mobile Shower Commode Chair\nCatalog Number Z100\nSeat Catalog Numbers:\nZVFIFAR17\nZVFIFAR 20\nZCSEAT (FAR)\nUDI-DI code: (01)00628758001003\nSerial Numbers:\nRAS217210\nRAS224711\nRAS214364\n\nFAR Seat (Demo)\nCatalog Numbers:\nZVFI17FAR-A\nZCSEAT-A\nUDI-DI code: N/A\nSerial Numbers: N/A", "firm_fei_number": "3006055387", "recalling_firm": "Raz Design Inc", "address_1": "82 Carnforth Rd", "city": "North York", "country": "Canada", "reason_for_recall": "Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.", "root_cause_description": "Use error", "action": "On 01/05/2025, the firm email an \"URGENT: MEDICAL DEVICE CORRECTION\" Letter to customers informing them that an incident was reported to Raz involving a Raz Mobile Shower Commode Chair with a certain Front and Rear Open (FAR) Seat. This incident in Canada involved an unauthorized modification of a FAR seat by a vendor, followed by reinstallation without properly engaging the outside rear seat brackets that keep the seat in place. This is not a supported configuration, and it resulted in one side of the seat halves slipping off the seat frame, which caused an injury to the user.\n\nCustomers are instructed to:\n1 Notify impacted customers using this Correction Notice and request that they return the Acknowledgement and Receipt Form to you.\n2 Raz will provide items to facilitate Correction. The items will be provided directly to the Sales Rep or to Dealer, whichever will execute the Correction action:\n3 Sales Rep or Dealer shall conduct a service visit with the impacted end-user.\n\nFor users/caregivers:\n1 Be sure that the FAR seat is properly installed and latched before a user is transferred onto the chair. The rear seat attachment bracket must be fully hooked under the rear seat support tube(s). The front seat attachment brackets must be securely latched around the front seat support tubes. Both front and rear seat attachment brackets should be secured in place by tightening the 8 screws on the underside of the seat.\n2 if seat needs to be removed for cleaning, follow instructions as per User & Dealer Manual proper removal and installation of the seat to ensure safe use of the chair prior to the installation of the FAR Seat Retrofit Kit.\n3 If you do not have a User and Dealer Manual, download a copy from www.razdesigninc.com, or contact Sales Rep or Dealer.\n\nFor questions or further assistance - contact Raz Design Inc by email at arahat@razdeigninc.com", "product_quantity": "66", "distribution_pattern": "U.S. Nationwide distribution in the states of CO, FL, IL, MA, MI, MN, MO, NC, NE, NH, NJ, NY, OR, PA, TX, WA, and WI.", "openfda": { "device_name": "Chair, Adjustable, Mechanical", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.3100", "device_class": "1", "k_number": [ "K812399", "K930520", "K821651", "K902600", "K896814", "K874060", "K923753", "K923095", "K922061", "K862885", "K945650", "K862883", "K862957", "K942397", "K882090", "K811484", "K921272", "K904069", "K841691", "K923752", "K923750", "K894767", "K902951", "K823277", "K812347", "K832511" ], "registration_number": [ "3015772781", "3006055387", "3021550572", "3017958559", "3005026814", "3010589475", "3013524663", "3010461764", "3006897028", "2432177", "3006541027", "3008729549", "3010113803", "9680333", "3018783415", "3021167963", "3007120364", "3008986539", "3027970365", "3004577612", "3003272910", "1317307", "3005555609", "3008058406", "3003162820", "3031595778", "2126684", "3044470904", "3016915446", "3004499949", "9615370", "3021327432", "3031233916", "3004905643", "3008555994", "3005720080", "3006481901", "3007160937", "3012271517", "1523547", "3009265647", "3006440543", "3001452523", "3012316249", "1833497", "3008485769", "3023189540", "3008651983", "3007082185", "3014683120", "3030244516", "3037609256", "3030488262", "3011522406", "3014270896", 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