Z-2516-2026Class II

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063...

Name: Z-2516-2026 Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063...
Creator: Inspire Medical Systems Inc.
Published: 2026-05-11
License: https://open.fda.gov/license/

Inspire Medical Systems Inc / initiated 2026-05-11 / Open, Classified / root cause: manufacturing process

FDA source

Inspire Medical Systems Inc. began a recall of Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire Stimulation Lead... on 2026-05-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2516-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-11
Posted: 2026-06-18
Recalling firm: Inspire Medical Systems Inc
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. 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
Product code: MNQ Stimulator, Hypoglossal Nerve, Implanted, Apnea
Reason for 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Firm began notifying consignees on May 11, 2026. Letters were titled "URGENT Medical Device Correction." The firm requests consignees' assistance in removing affected product from clinical inventory and returning them to Inspire.
Quantity in commerce: 10 impacted units
Distribution: Worldwide distribution - US Nationwide and the country of Hong Kong.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2516-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2515-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-18
Z-2516-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-24	2026-06-18

Product code MNQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)