{ "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": "2026-09-28", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "221959", "product_res_number": "Z-3262-2026", "event_date_initiated": "2026-08-18", "event_date_posted": "2026-09-24", "recall_status": "Open, Classified", "res_event_number": "99606", "product_code": "IOQ", "product_description": "PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and output valves to provide weight-based pressure redistribution whenever a patient moves or is repositioned, Model/Catalog Number: P3255A08", "code_info": "Serial Number: A171BP3769 - B057BP6765\nUDI-DI Number: 00887761007543", "firm_fei_number": "1417572", "recalling_firm": "Baxter Healthcare Corporation", "address_1": "1 Baxter Pkwy", "city": "Deerfield", "state": "IL", "postal_code": "60015-4625", "additional_info_contact": "Center for One Baxter\n1-847-9484770", "reason_for_recall": "There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or product specifications and may lead to incorrect product identification or selection, potentially resulting in use with an incompatible bed frame.", "root_cause_description": "Process control", "action": "An \"Urgent Medical Device Correction notification\" letter dated 8/18/26 was sent to customers.\n\nActions to be Taken by Customers\n1.Locate the affected product at your facility and confirm each Product Code.\nOnce product has been identified, use Hillrom pro+ Surface Instructions for Use (209196) (IFU) to assess the fit of the surfaces relative to the frame and siderails to confirm the surface is installed properly. If the surface does not meet the requirements set in the IFU please discontinue the use of this surface.\n2. A Baxter representative will contact your facility to replace the incorrect label when it becomes available.\n3. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at\nhttps://BaxterFieldActionCustomerPortal.onprocess.com even if you do not have any remaining inventory. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from Accenture LLP on behalf of Baxter to confirm your receipt of this notification.\n4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions.\n5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them.\n6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction.\n\n\nFor general questions regarding this communication, please contact Baxter Global Technical Service at 800-445-3720 Option 2 between 8:00 am and 6:00 pm Eastern Time Monday through Friday.", "product_quantity": "169 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the country of Canada.", "openfda": { "k_number": [ "K893614", "K875321", "K883192", "K912855", "K923977", "K915671", "K931594", "K863047", "K914674", "K840882", "K894723", "K871368", "K926189", "K905053", "K840881", "K880486", "K893708", "K905126", "K941610", "K882229", "K832829", "K973624", "K894353", "K910851", "K921768", "K122473", "K922973", "K926456", "K890935", "K901295", "K882177", "K871614", "K970295", "K912854", "K925694", "K771264", "K920382", "K882607", "K970364", "K905156", "K970363", "K940662", "K901890", "K903659", "K970636", "K951001", "K943433", "K914851", "K143414", "K945729", "K932480", "K864232", "K964873", "K922140", "K840697", "K893801", "K881843" ], "registration_number": [ "3014650138", "8043439", "1954156", "3017486514", "3011489684", "3007420694", "2032121", "3008058231", "3007309299", "3010010434", "3031218453", "8022290", "1824206", "2030595", "3003542872", "9710603", "3006697241", "2030732", "3036779619", "1931307", "1831750", "3012292104", "3009591865", "3007005431", "1834244" ], "fei_number": [ "3014650138", "3017486514", "3011489684", "3007420694", "3008058231", "3007309299", "3010010434", "3031218453", "3000204953", "1824206", "3003542872", "3003083675", "3006697241", "3003513125", "3000040879", "3036779619", "1931307", "1000220700", "1831750", "3004411059", "3012292104", "3009591865", "3007005431", "1000518730", "3002693132" ], "device_name": "Bed, Flotation Therapy, Powered", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.5170", "device_class": "2" } } ] }