--- title: "Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper A... — FDA record Z-0040-2025 | Is It on Recall" description: "Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box." url: https://isitonrecall.com/recall/fda-device-z-0040-2025-inspire-model-4340-respiratory-sensing-lead-component-of-the-inspire-upper-airway-stimulation-uas-sy/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system. — FDA record Z-0040-2025 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Jul 31, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system. - **Reason**: Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box. - **Classification**: Class II - **Recalling firm**: Inspire Medical Systems Inc. - **Quantity**: 152 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0040-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0040-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Model 4340. UDI-DI: 10855728005946. Part Number: 900-014-00. Serial Numbers: D59544, D59550, D59543, D59541, D59542, D59528, D59526, D59534, D59521, D59477, D59519, D59515, D59516, D59489, D59514, D59512, D59510, D59509, D59547, D59549, D59505, D59506, D59504, D59503, D59502, D59529, D59497, D59494, D59490, D59485, D59486, D56077, D56072, D56064, D56060, D56059, D56055, D56038, D56082, D56035, D56044, D56031, D56032, D56033, D56034, D56040, D56046, D56030, D56036, D56053, D56054, D56058, D55284, D48681, D48668, D48661, D48655, D48650, D48410, D46477, D46478, D43687, D43688, D43700, D48014, D48007, D47994, D47991, D47983, D47964, D47963, D47958, D47940, D45763, D47939, D45768, D47913, D47228, D47903, D47896, D47897, D47909, D47910, D47951, D45706, D45721, D45724, D47877, D47872, D47879, D47880, D47691, D47670, D47654, D47243, D47240, D47220, D47187, D47181, D47176, D47177, D47191, D47192, D47175, D47169, D47163, D47164, D47142, D47131, D47926, D47102, D47013, D47006, D46990, D46966, D46955, D46854, D46855, D46847, D46846, D46835, D46804, D46797, D46784, D47202, D46699, D46700, D46664, D46566, D46567, D46561, D46535, D46532, D46527, D46528, D46529, D46525, D46526, D46463, D46451, D45962, D45949, D45947, D45777, D45773, D45745, D45708, D44687, D44685, D44677, D44675, D26997. | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Oct 16, 2024 - **Recall initiation date**: Jul 31, 2024 - **Center classification date**: Oct 9, 2024 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0040-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Inspire Medical Systems Inc. records](https://isitonrecall.com/brand/inspire-medical-systems-inc/)