{"recall":{"id":"fda-device-99606","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Baxter Healthcare Corporation recalls 3 products","firm":"Baxter Healthcare Corporation","date":"2026-08-18","reported":"2026-09-30","status":"Ongoing","classification":"Class II","products":[{"name":"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":"Serial Number: A171BP3769 - B057BP6765 UDI-DI Number: 00887761007543","quantity":"169 units","number":"Z-3262-2026","classification":"Class II"},{"name":"PRO+ 36\" MRS SURFACE, 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: P7924A13","code":"Serial Number: A136BP2433 - B052BP6510 UDI-DI Number: 00887761007659","quantity":"824 units","number":"Z-3263-2026","classification":"Class II"},{"name":"PRO+ 40\" MRS SURFACE, 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: P7924A14","code":"Serial Number: A305BP8842 - A305BP8847 UDI-DI Number: 00887761007666","quantity":"6 units","number":"Z-3264-2026","classification":"Class II"}],"reason":"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide distribution - US Nationwide and the country of Canada.","nationwide":true,"states":[],"units":"169 units; 824 units; 6 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99606","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"dd70e5cd7311e104","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99606","record":[{"status":"Ongoing","city":"Deerfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99606","recalling_firm":"Baxter Healthcare Corporation","address_1":"1 Baxter Pkwy","address_2":"","postal_code":"60015-4625","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"Worldwide distribution - US Nationwide and the country of Canada.","recall_number":"Z-3262-2026","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","product_quantity":"169 units","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.","recall_initiation_date":"20260818","center_classification_date":"20260924","report_date":"20260930","code_info":"Serial Number: A171BP3769 - B057BP6765 UDI-DI Number: 00887761007543","more_code_info":""},{"status":"Ongoing","city":"Deerfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99606","recalling_firm":"Baxter Healthcare Corporation","address_1":"1 Baxter Pkwy","address_2":"","postal_code":"60015-4625","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"Worldwide distribution - US Nationwide and the country of Canada.","recall_number":"Z-3263-2026","product_description":"PRO+ 36\" MRS SURFACE, 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: P7924A13","product_quantity":"824 units","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.","recall_initiation_date":"20260818","center_classification_date":"20260924","report_date":"20260930","code_info":"Serial Number: A136BP2433 - B052BP6510 UDI-DI Number: 00887761007659","more_code_info":""},{"status":"Ongoing","city":"Deerfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99606","recalling_firm":"Baxter Healthcare Corporation","address_1":"1 Baxter Pkwy","address_2":"","postal_code":"60015-4625","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"","distribution_pattern":"Worldwide distribution - US Nationwide and the country of Canada.","recall_number":"Z-3264-2026","product_description":"PRO+ 40\" MRS SURFACE, 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: P7924A14","product_quantity":"6 units","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.","recall_initiation_date":"20260818","center_classification_date":"20260924","report_date":"20260930","code_info":"Serial Number: A305BP8842 - A305BP8847 UDI-DI Number: 00887761007666","more_code_info":""}]}}