Inspire Medical Systems Inc. recalls Brand Name: Inspire Medical Systems

Recalling company

Inspire Medical Systems Inc.

Product

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 – may cause temporary or medically reversible health consequences

Recall date

May 11, 2026

Reported

Jun 24, 2026

Distribution

Worldwide distribution - US Nationwide and the country of Hong Kong.

Status

Ongoing

Quantity

10 impacted units

Lot / codes

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

Company location

Golden Valley, MN

Recall type

Voluntary: Firm initiated

Recall number

Z-2516-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2516-2026 in the FDA Enforcement Report. Also see FDA recall press releases.