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Inspire Medical Systems Inc. FDA Recalls
5 recalls on file across devices, 1 of them Class I and 5 still open. Matched by name to INSP.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 SClass IIMay 11, 2026Products are labeled with incorrect Use By Date, extending b |
| Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product DClass IIMay 11, 2026Products are labeled with incorrect Use By Date, extending b |
| Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.Class IIJul 31, 2024Labeling error with a mismatch between the shelf box serial |
| Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.Class IIJul 31, 2024Labeling error with a mismatch between the shelf box serial |
| Inspire Model 3028, IV Implantable Pulse GeneratorClass IMay 16, 2024There is a potential manufacturing defect which can lead to |