{"url_path":"/fda/device/recalls/Z-2515-2026","section_key":"summary","section_title":"DEVICE Recall: Inspire Medical Systems Inc. — Brand Name: Inspire Medical Systems, Inc.  Product Name: Inspire Respiratory Sensing Lead  Model/Catalog Number: 4340  Software Version: N/A  Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiratio…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-11","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2515-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Inspire Medical Systems Inc."},"word_count":232,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2515-2026\n\n**Recalling firm:** Inspire Medical Systems Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-11\n**Report date:** 2026-06-24\n\n## Product\nBrand Name: Inspire Medical Systems, Inc.  Product Name: Inspire Respiratory Sensing Lead  Model/Catalog Number: 4340  Software Version: N/A  Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG).  Component: N/A\n\n## Reason\nProducts are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.\n\n## Affected lots\nLot Code: Model No 4340 (USA only lead); UDI-DI [4340] 10855728005946; Inspire part number [4340] 900-014-003;  serial numbers T18806, T45012, T45017, T49002, T67098, T67152, T69541, T69542, T69553, T69558, T69562  Model No 4340 (Global lead); UDI-DI [4340] 10810098650301; Inspire part number [4340] 900-014-005; serial numbers T91485, T91486, T91491, T91495, T91513, T91520, T91521, T91527, T91533, T91537, T91540, T91545, T96165, T96168, T96192, T96193, T96195, T96225, T96237, T98118, T98126, T98136, T98137, T98138, T98141, T98143, T98145, T98150, T98153, T98156, T98163, T98165, T98176, T98177, T98178, T98181, T98183, T98190, T96217\n\n## Distribution\nWorldwide  distribution - US Nationwide and the country of Hong Kong."}