Regulatory Record: Inspire Medical Systems Inc.

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Inspire Medical Systems Inc. has 2 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Enforcement history

On 2026-06-24, Argus HQ recorded a FDA recall for Inspire Medical Systems Inc., rated "high" severity in Argus HQ's classification: Inspire Medical Systems Inc. — Class II recall: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lea… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-24, Argus HQ recorded a FDA recall for Inspire Medical Systems Inc., rated "high" severity in Argus HQ's classification: Inspire Medical Systems Inc. — Class II recall: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sen… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, Inspire Medical Systems Inc. has 2 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations). Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Counting an FDA record here does not by itself indicate an unresolved problem -- warning letters, recalls, and inspection observations are frequently closed out once a firm completes FDA-required corrective action.

Frequently asked questions

Has Inspire Medical Systems Inc. had product recalls?

Yes, 2 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Inspire Medical Systems Inc. official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Inspire Medical Systems Inc. had?

Argus HQ has recorded 2 FDA events for Inspire Medical Systems Inc.: 0 warning letters, 2 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Inspire Medical Systems Inc.?

The most recent FDA event Argus HQ has on file for Inspire Medical Systems Inc. is dated 2026-06-24, with a severity rating of "high" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Related enforcement actions

• Inspire Medical Systems Inc. — Class II recall: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sen… →
• Inspire Medical Systems Inc. — Class II recall: Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lea… →

Compare with

• Inspire Medical Systems Inc. vs Medline Industries, LP
• Inspire Medical Systems Inc. vs ARROW INTERNATIONAL, LLC
• Inspire Medical Systems Inc. vs Stryker Sustainability Solutions
• Inspire Medical Systems Inc. vs Guardian Drug Co. Inc.
• Inspire Medical Systems Inc. vs B BRAUN MEDICAL INC