Exact FDA event identifier

Event 98990

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 11, 2026
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Inspire Medical Systems Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-2515-2026

Recall number: Z-2515-2026
Initiated: May 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Inspire Medical Systems Inc.
Quantity: 50 impacted units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

Worldwide distribution - US Nationwide and the country of Hong Kong.

device · product 2 of 2

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

Z-2516-2026

Recall number: Z-2516-2026
Initiated: May 11, 2026
Classification: Class II
Status: Ongoing
Recalling firm: Inspire Medical Systems Inc.
Quantity: 10 impacted units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

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

Distribution pattern

Worldwide distribution - US Nationwide and the country of Hong Kong.