{"recall":{"id":"fda-device-99247","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"3B Medical, Inc. recalls Brand Name: Rio\" II Product Name: Rio\" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small)","firm":"3B Medical, Inc.","date":"2023-06-15","reported":"2026-07-22","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: Rio\" II Product Name: Rio\" II Nasal Pillows Interface Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large) Software Version: N/A Product Description: Nasal pillows interface intended for use with positive airway pressure therapy devices. The device delivers airflow from a PAP device to the patient's nose and is secured using adjustable headgear. Component: No","code":"Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003 Affected Lots RII1001: 220121 220121 220191 RII1002: 220121 220121 220191 RII1003: 220121 220121 220191","quantity":"375","number":"Z-2740-2026","classification":"Class II"}],"reason":"Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution.","nationwide":true,"states":[],"units":"375","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=99247","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"0398b3e33efc7a37","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=99247","record":[{"status":"Ongoing","city":"Dublin","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99247","recalling_firm":"3B Medical, Inc.","address_1":"5475 Rings Rd Ste 550","address_2":"","postal_code":"43017-7537","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2740-2026","product_description":"Brand Name: Rio\" II  Product Name: Rio\" II Nasal Pillows Interface  Model/Catalog Number: RII1001 (Small), RII1002 (Medium), RII1003 (Large)  Software Version: N/A  Product Description: Nasal pillows interface intended for use with positive airway pressure therapy devices. The device delivers airflow from a PAP device to the patient's nose and is secured using adjustable headgear.  Component: No","product_quantity":"375","reason_for_recall":"Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN).","recall_initiation_date":"20230615","center_classification_date":"20260715","report_date":"20260722","code_info":"Lot Code: Affected Catalog Numbers: RII1001, RII1002, RII1003  Affected Lots RII1001: 220121 220121 220191  RII1002: 220121 220121 220191  RII1003: 220121 220121 220191","more_code_info":""}]}}