{"recall":{"id":"fda-device-99284","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Intersurgical Inc recalls 2 products","firm":"Intersurgical Inc","date":"2026-06-15","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.","code":"REF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.","quantity":"21,269 units","number":"Z-2952-2026","classification":"Class II"},{"name":"One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.","code":"REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.","quantity":"1,575 units","number":"Z-2953-2026","classification":"Class II"}],"reason":"Devices could potentially be occluded or partially occluded.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.","nationwide":true,"states":[],"units":"21,269 units; 1,575 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=99284","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"a1b72d5b615e5ea8","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=99284","record":[{"status":"Ongoing","city":"East Syracuse","state":"NY","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99284","recalling_firm":"Intersurgical Inc","address_1":"5010 Campuswood Dr Ste 102","address_2":"","postal_code":"13057-1561","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.","recall_number":"Z-2952-2026","product_description":"One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.","product_quantity":"21,269 units","reason_for_recall":"Devices could potentially be occluded or partially occluded.","recall_initiation_date":"20260615","center_classification_date":"20260814","report_date":"20260826","code_info":"REF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.","more_code_info":""},{"status":"Ongoing","city":"East Syracuse","state":"NY","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99284","recalling_firm":"Intersurgical Inc","address_1":"5010 Campuswood Dr Ste 102","address_2":"","postal_code":"13057-1561","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"US Nationwide distribution in the states of CT, FL, IN, MI, OH & VA.","recall_number":"Z-2953-2026","product_description":"One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.","product_quantity":"1,575 units","reason_for_recall":"Devices could potentially be occluded or partially occluded.","recall_initiation_date":"20260615","center_classification_date":"20260814","report_date":"20260826","code_info":"REF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.","more_code_info":""}]}}