Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2969-2018·Announced 2018-09-12

Inspire II Implantable Pulse Generator Recalled for Incorrect Use-By Date

Inspire Medical Systems is recalling 93 Inspire II Implantable Pulse Generators because the device registration labels contain an incorrect use-by date.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a minor labeling error (incorrect use-by date) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Inspire Medical Systems Inc. is recalling 93 Inspire II Model 3024 Implantable Pulse Generators (IPG) for Obstructive Sleep Apnea. The recall is due to an incorrect use-by date of 2018-01-14 printed on the device registration and patient file labels found in the literature packet included with the sterile tray.

The affected devices were distributed nationwide in the states of AL, AZ, CA, FL, GA, IL, KY, MA, MI, MN, MS, NY, OH, PA, TN, TX, VA, WA, and WI. The source text lists specific serial numbers for devices in customer stock and devices that have already been implanted in patients.

Healthcare providers and patients should verify the serial numbers of their devices against the list provided in the official recall notice. If a device is affected, the manufacturer is coordinating the recall to address the labeling error.

The recalled product

Product: Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients…
Manufacturer: Inspire Medical Systems Inc.
Category: Medical Device — Implantable Pulse Generator
Hazard: mis-labeling
Affected units: 93

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

device registration form
NCR202230H
NCR202238H
NCR202244H
NCR202245H
NCR202246H
NCR202247H
NCR202252H
NCR202253H
NCR202254H
NCR202255H
NCR202259H
NCR202260H
NCR202261H
NCR202264H
NCR202266H
NCR202267H
NCR202268H
NCR202269H
NCR202270H

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically:

Same manufacturer · Inspire Medical Systems Inc.

See all →

High
Inspire stimulation leads labeled with Use By dates beyond shelf life
FDA (Devices) · 2026-06-24
High
Inspire respiratory sensing leads labeled with Use By dates beyond shelf life
FDA (Devices) · 2026-06-24
Moderate
Inspire Model 4063 Stimulation Lead Labeling Error — Serial Number Mismatch
FDA (Devices) · 2024-10-16
Moderate
Inspire Respiratory Sensing Lead Model 4340 Serial Number Label Mismatch
FDA (Devices) · 2024-10-16
Severe
Inspire Model 3028 Implantable Pulse Generator Manufacturing Defect
FDA (Devices) · 2024-07-03

Same hazard · mis labeling