{"recall":{"id":"fda-device-99119","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Baxter Healthcare Corporation recalls 2 products","firm":"Baxter Healthcare Corporation","date":"2026-05-21","reported":"2026-07-08","status":"Ongoing","classification":"Class I","products":[{"name":"Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device","code":"UDI: 00887761981492; Lot Numbers: All lot numbers distributed beginning on 4/28/2025","quantity":"16187 units","number":"Z-2550-2026","classification":"Class I"},{"name":"Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device","code":"UDI: 10887761981499; Lot Numbers: All lot numbers distributed beginning on 4/28/2025","quantity":"13881 units","number":"Z-2551-2026","classification":"Class I"}],"reason":"There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits. The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.","hazard":"FDA Class I: a reasonable probability that use or exposure will cause serious adverse health consequences or death (FDA definition).","affected":"Worldwide distribution - US Nationwide and the country of Canada.","nationwide":true,"states":[],"units":"16187 units; 13881 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=99119","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"b8ec2545bb0a9d8d","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T22:17:07.772Z","history":[{"at":"2026-11-02T22:17:07.772Z","changes":["Product details, codes or quantities changed","Units: 10540 units; 0; 16187 units; 13881 units → 16187 units; 13881 units"]}]},"official":{"fetchedAt":"2026-11-02T22:17:07.772Z","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=99119","record":[{"status":"Ongoing","city":"Deerfield","state":"IL","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99119","recalling_firm":"Baxter Healthcare Corporation","address_1":"1 Baxter Pkwy","address_2":"N/A","postal_code":"60015-4625","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the country of Canada.","recall_number":"Z-2550-2026","product_description":"Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device","product_quantity":"16187 units","reason_for_recall":"There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.  The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.","recall_initiation_date":"20260521","center_classification_date":"20260701","report_date":"20260708","code_info":"UDI: 00887761981492; Lot Numbers: All lot numbers distributed beginning on 4/28/2025"},{"status":"Ongoing","city":"Deerfield","state":"IL","country":"United States","classification":"Class I","openfda":{},"product_type":"Devices","event_id":"99119","recalling_firm":"Baxter Healthcare Corporation","address_1":"1 Baxter Pkwy","address_2":"N/A","postal_code":"60015-4625","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide distribution - US Nationwide and the country of Canada.","recall_number":"Z-2551-2026","product_description":"Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device","product_quantity":"13881 units","reason_for_recall":"There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system patient circuits.  The leakage can lead to an oxygen level drop in the patient and ineffective nebulization, which may affect the delivery of the prescribed treatment. The issue has been associated with improper locking of the nebulizer cup after adding medication during user setup.","recall_initiation_date":"20260521","center_classification_date":"20260701","report_date":"20260708","code_info":"UDI: 10887761981499; Lot Numbers: All lot numbers distributed beginning on 4/28/2025"}]}}