{"url_path":"/fda/device/recalls/Z-2953-2026","section_key":"summary","section_title":"DEVICE Recall: Intersurgical Inc — One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. 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-2953-2026%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":85,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2953-2026\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 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.\n\n## Reason\nDevices could potentially be occluded or partially occluded.\n\n## Affected lots\nREF: 1000035; Single Unit UDI: 5030267049844; Case UDI: 05030267044528; Lot No. 32190425, 32213076, 32221283, 32307261, 32317627, 32321305, 32513841, 32517565.\n\n## Distribution\nUS Nationwide distribution in the states of CT, FL, IN, MI, OH & VA."}