{"recall":{"id":"fda-device-99295","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"INTEGRATED MEDCRAFT LLC recalls 2 products","firm":"INTEGRATED MEDCRAFT LLC","date":"2026-07-07","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.","code":"FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Lot Numbers: IMC-00000060, IMC-00000066, IMC-00000078, IMC-00000086, IMC-00000092, IMC-00000096, IMC-00000096, IMC-00000097, IMC-00000103, IMC-00000110, IMC-00000125, IMC-00000151, IMC-00000200, IMC-00000201, IMC-00000204, IMC-00000205. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. Lot Numbers: 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154. 2. Size 000, ISO 3.5, light green. Product Code: 1000035. Lot Numbers: 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565","quantity":"509 units","number":"Z-2836-2026","classification":"Class II"},{"name":"Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.","code":"Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Lot Numbers: IMC-00000132, IMC-00000139. Containing the affected One-piece Guedel airway components 1. Size 00, ISO 5.0, blue. Product Code: 1100050. Lot Numbers: 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154. 2. Size 000, ISO 3.5, light green. Product Code: 1000035. Lot Numbers: 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565","quantity":"","number":"Z-2837-2026","classification":"Class II"}],"reason":"Devices could potentially contain an occluded or partially occluded Guedel Airway tip.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution.","nationwide":true,"states":[],"units":"509 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=99295","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"5bbded7975e92290","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=99295","record":[{"status":"Ongoing","city":"East Hampton","state":"CT","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99295","recalling_firm":"INTEGRATED MEDCRAFT LLC","address_1":"1 Sinco Pl Unit A10","address_2":"","postal_code":"06424-2129","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2836-2026","product_description":"FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002.     Containing the affected One-piece Guedel airway components:   1. Size 00, ISO 5.0, blue. Product Code: 1100050.     2. Size 000, ISO 3.5, light green. Product Code: 1000035.","product_quantity":"509 units","reason_for_recall":"Devices could potentially contain an occluded or partially occluded Guedel Airway tip.","recall_initiation_date":"20260707","center_classification_date":"20260731","report_date":"20260812","code_info":"FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Lot Numbers: IMC-00000060, IMC-00000066, IMC-00000078, IMC-00000086, IMC-00000092, IMC-00000096, IMC-00000096, IMC-00000097, IMC-00000103, IMC-00000110, IMC-00000125, IMC-00000151, IMC-00000200, IMC-00000201, IMC-00000204, IMC-00000205.   Containing the affected One-piece Guedel airway components:  1. Size 00, ISO 5.0, blue. Product Code: 1100050. Lot Numbers: 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.   2. Size 000, ISO 3.5, light green. Product Code: 1000035. Lot Numbers: 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565","more_code_info":""},{"status":"Ongoing","city":"East Hampton","state":"CT","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99295","recalling_firm":"INTEGRATED MEDCRAFT LLC","address_1":"1 Sinco Pl Unit A10","address_2":"","postal_code":"06424-2129","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-2837-2026","product_description":"Kingfisher Compact Individual First Aid Kit. REF Number: 76656.     Containing the affected One-piece Guedel airway components:    1. Size 00, ISO 5.0, blue. Product Code: 1100050.     2. Size 000, ISO 3.5, light green. Product Code: 1000035.","product_quantity":"","reason_for_recall":"Devices could potentially contain an occluded or partially occluded Guedel Airway tip.","recall_initiation_date":"20260707","center_classification_date":"20260731","report_date":"20260812","code_info":"Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Lot Numbers: IMC-00000132, IMC-00000139.  Containing the affected One-piece Guedel airway components  1. Size 00, ISO 5.0, blue. Product Code: 1100050. Lot Numbers: 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.  2. Size 000, ISO 3.5, light green. Product Code: 1000035. Lot Numbers: 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565","more_code_info":""}]}}