{"recall":{"id":"fda-device-99681","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Baxter Healthcare Corporation recalls Brand Name: VOLARA System Product Name: VOLARA","firm":"Baxter Healthcare Corporation","date":"2026-08-03","reported":"2026-09-30","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No","code":"Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853","quantity":"2","number":"Z-3257-2026","classification":"Class II"}],"reason":"Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of Colorado and Florida.","nationwide":true,"states":[],"units":"2","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=99681","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"ed4b1c6fa7162bc4","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=99681","record":[{"status":"Ongoing","city":"Deerfield","state":"IL","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99681","recalling_firm":"Baxter Healthcare Corporation","address_1":"1 Baxter Pkwy","address_2":"","postal_code":"60015-4625","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Telephone","distribution_pattern":"US Nationwide distribution in the states of Colorado and Florida.","recall_number":"Z-3257-2026","product_description":"Brand Name: VOLARA System  Product Name: VOLARA, HC, NA A  Model/Catalog Number: M08594A  Software Version: N/A  Product Description: VOLARA, HOMECARE, NORTH AMERICA  Component: No","product_quantity":"2","reason_for_recall":"Contamination within the release test equipment flow path could have affected the accuracy of the  nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.","recall_initiation_date":"20260803","center_classification_date":"20260923","report_date":"20260930","code_info":"Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853","more_code_info":""}]}}