⚠ 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-2515-2026
- Brand
- Inspire Medical Systems
- Classification
- Class II
- Units affected
- 50 impacted units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. 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 No 4340 (USA only lead); UDI-DI [4340] 10855728005946; Inspire part number [4340] 900-014-003; serial numbers T18806, T45012, T45017, T49002, T67098, T67152, T69541, T69542, T69553, T69558, T69562 Model No 4340 (Global lead); UDI-DI [4340] 10810098650301; Inspire part number [4340] 900-014-005; serial numbers T91485, T91486, T91491, T91495, T91513, T91520, T91521, T91527, T91533, T91537, T91540, T91545, T96165, T96168, T96192, T96193, T96195, T96225, T96237, T98118, T98126, T98136, T98137, T98138, T98141, T98143, T98145, T98150, T98153, T98156, T98163, T98165, T98176, T98177, T98178, T98181, T98183, T98190, T96217
- 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 24, 2026 at 2:00 AM UTC.
Report a data error on this page