{"url_path":"/fda/device/recalls/Z-2209-2026","section_key":"summary","section_title":"DEVICE Recall: TANGENT ENDOSCOPY, LLC — Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers:     (1) TNG4002-IND.   (2) TNG-4007-6pk.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-23","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2209-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"TANGENT ENDOSCOPY, LLC"},"word_count":95,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2209-2026\n\n**Recalling firm:** TANGENT ENDOSCOPY, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-23\n**Report date:** 2026-05-27\n\n## Product\nTangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers:     (1) TNG4002-IND.   (2) TNG-4007-6pk.\n\n## Reason\nAffected devices exhibited fractures at the distal shaft tip without complete detachment.\n\n## Affected lots\n(1) Model Number: TNG4002-IND; UDI-DI: (1) 00850061601001; Lot numbers: 2510900, 2512938, and 2601944.  (2) Model Number: TNG-4007-6pk; UDI-DI: 00850061601001; Lot numbers: 2510900, 2512938, and 2601944\n\n## Distribution\nUS Nationwide distribution in the states of North Carolina, Arizona, and Nevada."}