FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Medical device · Recalled June 24, 2026

Brand Name recall — Inspire Medical Systems Inc.

Hazard: 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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-2516-2026
Brand
Inspire Medical Systems
Classification
Class II
Units affected
10 impacted units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

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

Affected products

Companies & origin

Recalling firm location
Golden Valley, MN, United States
Firm address
5500 Wayzata Blvd Ste 1600, 55416-1237

Identifying details (verbatim from the notice)

Product codes / lots
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
Distribution
Worldwide distribution - US Nationwide and the country of Hong Kong.
Firm notified the public via
Letter
FDA event ID
98990
Recall initiated
May 11, 2026
FDA classified
June 18, 2026
FDA report date
June 24, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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