# FDA recall Z-2515-2026

> **Inspire Medical Systems Inc.** · Class II · device recall initiated 2026-05-11.

## 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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-2515-2026
- **Recalling firm:** Inspire Medical Systems Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-05-11
- **Report date:** 2026-06-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Golden Valley, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2515-2026

## Citation

> MORVS. FDA recall Z-2515-2026. Retrieved 2026-10-18 from https://api.morvs.ai/recall/Z-2515-2026. Source: US FDA. Licensed CC0.

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