Quick Facts at a Glance
- Recall Date
- May 11, 2026
- Hazard Level
- HIGH
- Brand
- Inspire Medical Systems
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Inspire Medical Systems
- Model numbers
- 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 +7 more
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 11, 2026
Reported by FDA DEVICE
June 24, 2026
RecallRadar source check
June 30, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Inspire Medical Systems Inc. or your healthcare provider for instructions. Notification method: Letter
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Full Description
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. Reason: 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.. Classification: Class II. Quantity: 10 impacted units. Distribution: Worldwide distribution - US Nationwide and the country of Hong Kong.
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Safety Guide
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