What is this medical device recall about?

This medical device recall concerns Brand Name: Inspire Medical Systems, associated with Inspire Medical Systems Inc.. It was reported based on a labeling or packaging error. See the "What Happened" and "Reason" sections above for a full plain-language explanation.

Is every unit of Brand Name: Inspire Medical Systems affected?

Not necessarily. Recalls and device actions typically apply to specific lots, batches, or serial number ranges rather than every unit ever distributed. Check the identifying details in the official FDA record against your specific product before assuming it is affected.

Should I stop using Brand Name: Inspire Medical Systems immediately?

Do not make that decision without guidance. For a prescription medication, abruptly stopping treatment can carry its own risks — talk to your prescriber or pharmacist first. For a device, ask the supplier or clinician about a safe replacement plan before discontinuing use on your own.

What recall classification applies here, and what does it mean?

This notice is classified Class II. Class I is the most serious (reasonable probability of serious harm or death), Class II involves a remote probability of serious harm with possible temporary effects, and Class III is unlikely to cause any adverse health consequence but violates FDA regulations.

Brand Name: Inspire Medical Systems Device Recall (Class II): What Patients Need to Know

Brand Name: Inspire Medical Systems Medical Device Recalled: Class II Recall Explained

Brand Name: Inspire Medical Systems is the subject of a medical device recall classified as Class II, associated with Inspire Medical Systems Inc.. This article explains what happened, which devices are affected, the health risks involved, and the recommended steps for patients, caregivers, and device users, based on official FDA…

July 6, 2026Sourced from FDA.gov

Overview

A medical device recall is an action taken to correct or remove a device from the market when it may pose a health risk or fails to perform as intended. Device recalls range from a simple software patch or a labeling correction to a full removal of the product from circulation, depending on how serious the underlying issue is.

This specific medical device recall involving Brand Name: Inspire Medical Systems is classified as Class II, and was reported on June 24, 2026 by Inspire Medical Systems Inc..

The sections below explain, in plain language, what is known about this medical device recall, who it may affect, and what steps patients and caregivers can reasonably take. This article is an independent summary written for educational purposes and is not a substitute for the official FDA notice linked at the end of this page.

What Happened

Inspire Medical Systems Inc. initiated action on Brand Name: Inspire Medical Systems on June 24, 2026 after identifying a labeling or packaging error. The action affects specific lots or units of this device rather than every unit ever produced, so not every package on the market is necessarily involved.

The action is described in FDA records as voluntary: firm initiated, and its current status in FDA records is listed as "Ongoing". Recall status can change as the firm works through correction or removal, so the most current information is always the official FDA recall record linked below.

Affected Products

The product identified in this notice is Brand Name: Inspire Medical Systems, manufactured or distributed by Inspire Medical Systems Inc..

FDA records describe the affected product as: 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.…

Identifying details on record include specific lot numbers, batch codes, or serial numbers documented as 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]…; a reported quantity of 10 impacted units; distribution reported as Worldwide distribution - US Nationwide and the country of Hong Kong.; origin or reporting location of Golden Valley, MN, United States. If you have this product, compare it against these identifiers before assuming it is affected — many recalls apply to only a subset of lots, not an entire product line.

Reason

Based on FDA records, this notice was driven by a labeling or packaging error. In general terms, this kind of issue is flagged because it has the potential to affect how safely or effectively the product performs once it reaches a patient.

Brand Name: Inspire Medical Systems Medical Device Recalled: Class II Recall Explained

Overview

What Happened

Affected Products

Reason

Health Risks

Recommended Actions

Who Should Be Concerned

Important Dates

Key Takeaways

Official FDA Source

Frequently Asked Questions

What is this medical device recall about?

Is every unit of Brand Name: Inspire Medical Systems affected?

Should I stop using Brand Name: Inspire Medical Systems immediately?

What recall classification applies here, and what does it mean?

References

Medicines Mentioned in This Article