CLASS II ONGOING Device recall · Reported 24 Jun 2026 · FDA Enforcement Report
Inspire stimulation Lead recalled by Inspire Medical Systems
Inspire Medical Systems is recalling Inspire stimulation Lead, distributed nationwide in the US. The recall was initiated on 11 May 2026 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-2516-2026
- FDA event ID
- 98990
- Recalling firm
- Inspire Medical Systems, Golden Valley, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 May 2026
- FDA classified
- 18 Jun 2026
- Reported
- 24 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 11 May 2026 | Recall initiated by company | |
| 18 Jun 2026 | Classified by FDA | +38 days |
| 24 Jun 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products 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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A
Where it was distributed
Worldwide distribution - US Nationwide and the country of Hong Kong.
Questions about this recall
Why was it recalled?
Products 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.
Which lots are affected?
Lot Code: Model 4063 (USA only lead); UDI-DI [4063] 10855728005793; Inspire part number [4063] 900-013-001; serial numbers D53393, D61104 Model 4063 (Global lead); UDI-DI [4063] 10810098650295, Inspire part number [4063] 900-013-003; serial numbers D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959
Where was it sold?
Worldwide distribution - US Nationwide and the country of Hong Kong.
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 98990| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Inspire Respiratory Sensing Lead recalled by Inspire Medical Systems | Inspire Medical Systems | Potency & Assay | 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 Model 4063 Stimulation Lead, component of the Inspire Upper recalled | Inspire Medical Systems | Labeling Errors | Nationwide |
| Device | CLASS II | Inspire Model 4340 Respiratory Sensing Lead 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 |
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|---|---|---|---|---|---|
| Device | CLASS II | NOxBOXi Nitric Oxide Delivery System recalled | Noxbox | Device Malfunction | Nationwide |
| Device | CLASS II | Palacos R pro recalled by Heraeus Medical GmbH (Dental | Heraeus Medical GmbH (Dental Division) | Packaging Defects | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065 recalled | Percussionaire | Other | Nationwide |
| Device | CLASS II | Positron Emission Tomography and Computed Tomography System recalled | Shanghai United Imaging Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Intrapulmonary Percussive Ventilation, IPV-1C recalled by Percussionaire | Percussionaire | Other | Nationwide |