Inspire Medical Systems Inc.: 5 recalls on record

Recalls filed with 1 agency: FDA (5).

First recall on record: July 3, 2024. Most recent: June 24, 2026.

Risk classification: Class I: 1 · Class II: 4

Most recent recalls

DateAgencyProduct
June 24, 2026FDABrand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/…Z-2516-2026
June 24, 2026FDABrand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead…Z-2515-2026
October 16, 2024FDAInspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (U…Z-0041-2025
October 16, 2024FDAInspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimul…Z-0040-2025
July 3, 2024FDAInspire Model 3028, IV Implantable Pulse GeneratorZ-2159-2024

Questions about this company

How many recalls does Inspire Medical Systems Inc. have?
Recalert has 5 U.S. recalls on record for Inspire Medical Systems Inc., published between July 3, 2024 and June 24, 2026.
What was the most recent Inspire Medical Systems Inc. recall?
FDA recall Z-2516-2026, published June 24, 2026: 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 s…
Which agencies have handled Inspire Medical Systems Inc. recalls?
Inspire Medical Systems Inc. appears as the recalling firm in recalls from: FDA (5).

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