Lower risk Medical device recall · FDA · Published May 11, 2026

Inspire Stimulation Lead Recall: Incorrect Use By Date Extends Shelf Life Risk

Inspire Medical Systems recalls Model 4063 stimulation leads with incorrect Use By Dates that may lead to unplanned surgery. Affected units have specific serial numbers and were sold in the US. Contact for remedy details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2516-2026Medical device Inspire Medical Systems ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmInspire Medical Systems Inc.5500 Wayzata Blvd Ste 1600 · Golden Valley, MN 55416-1237

✎ GovInfoNow plain-language explainer

Inspire Medical Systems is recalling Model 4063 stimulation leads because they have incorrect expiration dates that could lead to unplanned surgery. This risk occurs when the leads degrade past their valid shelf life. Read more at govinfonow.com/recall/49185-inspire-stimulation-lead-recall-incorrect-use-by-date-extends-shelf.

Source Summary by GovInfoNow · govinfonow.com/recall/49185-inspire-stimulation-lead-recall-incorrect-use-by-date-extends-shelf · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2516-2026

Cite this page

“Inspire Stimulation Lead Recall: Incorrect Use By Date Extends Shelf Life Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49185-inspire-stimulation-lead-recall-incorrect-use-by-date-extends-shelf. Based on FDA recall #Z-2516-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2516-2026%22&limit=1).

The FDA announced on May 11, 2026, that Inspire Medical Systems Inc. is recalling Inspire stimulation Lead Model 4063 devices due to incorrect Use By Dates extending beyond the validated shelf life. This labeling error may cause material degradation and unplanned revision surgery. Owners should contact the manufacturer for a replacement.

How to tell if you have it

Brand: Inspire Medical Systems
Product Name: Inspire stimulation Lead
Model/Catalog Number: 4063
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
Sold worldwide including the US and Hong Kong

The hazard

According to the FDA, products are labeled with an incorrect Use By Date that extends beyond the validated three-year shelf life from the date of manufacture. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

Context

GovInfoNow's records show Inspire Medical Systems Inc. has had three other recalls since June 12, 2018. Other recent recalls of similar products include Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation (May 13, 2026), Medtronic Pocket Adaptor Kits with Incorrect Use-By Dates Recalled (May 13, 2026), and HiResolution Bionic Ear System Recall (April 30, 2026).

How to tell if you have this one

Check for Model 4063 stimulation leads with serial numbers D53393, D61104, D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959 in the US. These units were sold with incorrect expiration dates.

Brand
Inspire Medical Systems
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the country of Hong Kong.

Recall number	Product, codes & lots	Quantity
Z-2515-2026	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; 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	50 impacted units
Z-2516-2026	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 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; 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	10 impacted units

Based on the official FDA remedy

What to do — step by step

Check Product Serial Number
Look for serial numbers D53393, D61104, D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959 on the lead.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the country of Hong Kong.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 44 days after the firm started it.

May 11, 2026Firm started the recall
Jun 18, 2026FDA classified it Class II
Jun 24, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/49185-inspire-stimulation-lead-recall-incorrect-use-by-date-extends-shelf">Inspire Stimulation Lead Recall: Incorrect Use By Date Extends Shelf Life Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2516-2026 (May 11, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2516-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.