{"url_path":"/fda/device/recalls/Z-2952-2026","section_key":"summary","section_title":"DEVICE Recall: Intersurgical Inc — One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-06-15","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2952-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Intersurgical Inc"},"word_count":88,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2952-2026\n\n**Recalling firm:** Intersurgical Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-06-15\n**Report date:** 2026-08-26\n\n## Product\nOne-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.\n\n## Reason\nDevices could potentially be occluded or partially occluded.\n\n## Affected lots\nREF: 1100050; Single Unit UDI: 5030267050185; Case UDI: 05030267044450; Lot No. 32121232, 32208193, 32400267, 32403734, 32408819, 32409672, 32416545, 32427064, 32605471, 32606405, 32606850, 32607154.\n\n## Distribution\nUS Nationwide distribution in the states of CT, FL, IN, MI, OH & VA."}