CLASS II ONGOING Device recall · Reported 16 Oct 2024 · FDA Enforcement Report
Inspire Model 4340 Respiratory Sensing Lead recalled
Inspire Medical Systems is recalling Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire, distributed nationwide in the US. The recall was initiated on 31 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0040-2025
- FDA event ID
- 95230
- Recalling firm
- Inspire Medical Systems, Golden Valley, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Jul 2024
- FDA classified
- 9 Oct 2024
- Reported
- 16 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- CPAP & Ventilators
Timeline
| 31 Jul 2024 | Recall initiated by company | |
| 9 Oct 2024 | Classified by FDA | +70 days |
| 16 Oct 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Product as listed by the FDA
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.
Questions about this recall
Why was it recalled?
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Which lots are affected?
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.
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 95230| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Inspire Model 4063 Stimulation Lead, component of the Inspire Upper recalled | Inspire Medical Systems | Labeling Errors | Nationwide |
More recalls from Inspire Medical Systems
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Inspire Respiratory Sensing Lead recalled by Inspire Medical Systems | Inspire Medical Systems | Potency & Assay | Nationwide |
| Device | CLASS II | Inspire stimulation Lead recalled by Inspire Medical Systems | Inspire Medical Systems | Potency & Assay | Nationwide |
| Device | CLASS II | Inspire Model 4063 Stimulation Lead, component of the Inspire Upper recalled | Inspire Medical Systems | Labeling Errors | Nationwide |
| Device | CLASS I | Inspire Model 3028, IV Implantable Pulse Generator recalled | Inspire Medical Systems | Packaging Defects | Nationwide |
| Device | CLASS II | Inspire II recalled by Inspire Medical Systems | Inspire Medical Systems | Other | Nationwide |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |