Inspire Medical Systems recalls

Inspire Medical Systems has 6 recalls on record with the FDA and USDA, the earliest in 2018 and the latest reported on 24 Jun 2026. 5 are still ongoing. 2 were reported in the last 12 months. The most frequent reason is lead & heavy metals.

Total recalls6since 2018

Last 12 months2reported

Class I117% of total

Ongoing5latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

2Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 2 0Jul 0 0

Severity split

Class I 1 17%Class II 5 83%Class III 0 0%

Why inspire medical systems is recalled

Product types

By year

2026233%
2024350%
2018117%

Ongoing inspire medical systems recalls

5 active

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Inspire Respiratory Sensing Lead recalled by Inspire Medical Systems	Inspire Medical Systems	Lead & Heavy Metals	Nationwide
24 Jun 2026Device	CLASS II	Inspire stimulation Lead recalled by Inspire Medical Systems	Inspire Medical Systems	Lead & Heavy Metals	Nationwide
16 Oct 2024Device	CLASS II	Inspire Model 4063 Stimulation Lead, component of the Inspire Upper recalled	Inspire Medical Systems	Labeling Errors	Nationwide
16 Oct 2024Device	CLASS II	Inspire Model 4340 Respiratory Sensing Lead recalled	Inspire Medical Systems	Labeling Errors	Nationwide
3 Jul 2024Device	CLASS I	Inspire Model 3028, IV Implantable Pulse Generator recalled	Inspire Medical Systems	Lead & Heavy Metals	Nationwide

All inspire medical systems recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Device	CLASS II	Inspire Respiratory Sensing Lead recalled by Inspire Medical Systems	Inspire Medical Systems	Lead & Heavy Metals	Nationwide
24 Jun 2026Device	CLASS II	Inspire stimulation Lead recalled by Inspire Medical Systems	Inspire Medical Systems	Lead & Heavy Metals	Nationwide
16 Oct 2024Device	CLASS II	Inspire Model 4063 Stimulation Lead, component of the Inspire Upper recalled	Inspire Medical Systems	Labeling Errors	Nationwide
16 Oct 2024Device	CLASS II	Inspire Model 4340 Respiratory Sensing Lead recalled	Inspire Medical Systems	Labeling Errors	Nationwide
3 Jul 2024Device	CLASS I	Inspire Model 3028, IV Implantable Pulse Generator recalled	Inspire Medical Systems	Lead & Heavy Metals	Nationwide
12 Sep 2018Device	CLASS II	Inspire II recalled by Inspire Medical Systems	Inspire Medical Systems	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.