{"recall":{"id":"fda-device-99299","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Freudenberg Medical, LLC recalls 2 products","firm":"Freudenberg Medical, LLC","date":"2026-06-17","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF","code":"Lot #0000369233/UDI: 00813307014133","quantity":"12 units","number":"Z-2909-2026","classification":"Class II"},{"name":"Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF","code":"Lot #0000369205/UDI: 00813307014232","quantity":"40 units","number":"Z-2910-2026","classification":"Class II"}],"reason":"Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.","nationwide":true,"states":[],"units":"12 units; 40 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=99299","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"6bb5bb7d92cc83db","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=99299","record":[{"status":"Ongoing","city":"Carpinteria","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99299","recalling_firm":"Freudenberg Medical, LLC","address_1":"1110 Mark Ave","address_2":"","postal_code":"93013-2918","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.","recall_number":"Z-2909-2026","product_description":"Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm  REF: 1610-LEF","product_quantity":"12 units","reason_for_recall":"Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.","recall_initiation_date":"20260617","center_classification_date":"20260806","report_date":"20260812","code_info":"Lot #0000369233/UDI: 00813307014133","more_code_info":""},{"status":"Ongoing","city":"Carpinteria","state":"CA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99299","recalling_firm":"Freudenberg Medical, LLC","address_1":"1110 Mark Ave","address_2":"","postal_code":"93013-2918","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution in the states of IN, OH, AZ, WA, FL, MO, KY, IN, NY and the countries of GBR, FRA.","recall_number":"Z-2910-2026","product_description":"Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm  REF: 1610-LF","product_quantity":"40 units","reason_for_recall":"Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flange contains a Large Esophageal Flange.","recall_initiation_date":"20260617","center_classification_date":"20260806","report_date":"20260812","code_info":"Lot #0000369205/UDI: 00813307014232","more_code_info":""}]}}