RegWardenFDA facility compliance records
Company

Inspire Medical Systems Inc.

4 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2018: 1 recalls; 2024: 2 recalls; 2026: 1 recalls2017120182019202020212022202322024202512026
  • Recalls (4)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2026-05-11
    Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.
  • Class IIOngoing2024-07-31
    Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
  • Class IOngoing2024-05-16
    There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,
  • Class IITerminated2018-06-12
    Incorrect use-by date on the device registration/patient file labels.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Inspire Medical Systems Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10046749-inspire-medical-systems-inc/

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