The Recall Desk

FDA (Devices) recall action 98990

Inspire Medical Systems Inc. recalled 2 products on 2026-06-24

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2026-06-24
Critical
0
Units
60

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2026-06-24

    Inspire stimulation leads labeled with Use By dates beyond shelf life

    Inspire Stimulation Leads, model 4063, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 10 units affected.

    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.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2026-06-24

    Inspire respiratory sensing leads labeled with Use By dates beyond shelf life

    Inspire Respiratory Sensing Leads, model 4340, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 50 units affected.

    Product
    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 pres
    Category
    Distribution
    0 states