Key facts
| Recalling firm | Inspire Medical Systems Inc. |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | 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 |
| Classification | Class II |
| Recall number | Z-2515-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| 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. |
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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 (additional items listed in FDA's full record) -- and the recall number Z-2515-2026. If it matches, stop using or distributing it and contact Inspire Medical Systems Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Inspire Medical Systems Inc. and the affected product is described in FDA's record as: 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 (additional items listed in FDA's full record). FDA's stated reason for the recall is: 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.. The recall is tracked under FDA recall number Z-2515-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
Inspire Medical Systems Inc.’s FDA history
Argus HQ has recorded 2 total FDA actions tied to Inspire Medical Systems Inc.: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- Has Inspire Medical Systems Inc. had other FDA recalls or enforcement actions?
- Yes. Argus HQ has recorded 2 total FDA actions tied to Inspire Medical Systems Inc., including 2 recalls and 0 warning letters.
- What is the FDA recall number for this event?
- FDA recall number Z-2515-2026.
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
- Where can I verify this recall directly with FDA?
- The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
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Related enforcement actions
Full FDA history for Inspire Medical Systems Inc.Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Class II Recall: Brand Name: Inspire Medical Systems, Inc. Product Name:… by Inspire Medical Systems Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-inspire-medical-systems-inc-z-2515-2026
"FDA Class II Recall: Brand Name: Inspire Medical Systems, Inc. Product Name:… by Inspire Medical Systems Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-inspire-medical-systems-inc-z-2515-2026.
Argus HQ Research. "FDA Class II Recall: Brand Name: Inspire Medical Systems, Inc. Product Name:… by Inspire Medical Systems Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-inspire-medical-systems-inc-z-2515-2026.
@misc{argushq_argushq_ai_recall_fda_recall_inspire_medical_systems_inc_z_2515_2026_2026,
title = {FDA Class II Recall: Brand Name: Inspire Medical Systems, Inc. Product Name:… by Inspire Medical Systems Inc.},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/fda-recall-inspire-medical-systems-inc-z-2515-2026},
note = {Accessed: July 13, 2026}
}Source: FDA.gov — Recalls ↗