Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Inspire Medical Systems with 6 device recalls. The most recent is a device recall dated May 11, 2026: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| May 11, 2026 | Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The InspClass II · Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manuf | Device recalls |
| May 11, 2026 | Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/AClass II · Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manuf | Device recalls |
| Jul 31, 2024 | Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.Class II · Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in t | Device recalls |
| Jul 31, 2024 | Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.Class II · Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in t | Device recalls |
| May 16, 2024 | Inspire Model 3028, IV Implantable Pulse GeneratorClass I · There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a sys | Device recalls |
| Jun 12, 2018 | Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The deviClass II · Incorrect use-by date on the device registration/patient file labels. | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
