Z-2515-2026Class II

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog...

Name: Z-2515-2026 Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog...
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 Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description... 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-2515-2026
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 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
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: 50 impacted units
Distribution: Worldwide distribution - US Nationwide and the country of Hong Kong.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2515-2026
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)