Golden Valley, MN, United States
Inspire Medical Systems Inc. recalls
4 recalls recorded since 2018, most recently on 11 May 2026. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)3
Terminated or completed1
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 11 May 2026
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the country of Hong Kong.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2516-2026, Z-2515-2026
- 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 hyp
- 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 des
Ongoing Class II Medical devices
- Recall started
- 31 July 2024
- Reason
- Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Belgium, Switzerland, Germany, United Kingdom, Netherlands, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0040-2025, Z-0041-2025
- Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
- Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Ongoing Class I Medical devices
- Recall started
- 16 May 2024
- Reason
- There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,
- Distribution
- Worldwide distribution - US Nationwide and the country of Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2159-2024
- Inspire Model 3028, IV Implantable Pulse Generator
Terminated Class II Medical devices
- Recall started
- 12 June 2018
- Terminated
- 21 May 2019
- Reason
- Incorrect use-by date on the device registration/patient file labels.
- Distribution
- US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, KY, MA, MI, MN, MS, NY, OH, PA, TN, TX, VA, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2969-2018
- Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) syste
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.