The Recall Desk
HighFDA (Devices)·Z-2516-2026·Announced 2026-06-24

[pending] Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Num

Pending LLM rewrite. Source: FDA_DEVICE Z-2516-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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 recalled product

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.
Manufacturer
Inspire Medical Systems Inc.
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (15)

  • 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

Distributed nationwide across the United States.

Related recalls

Same category