Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0040-2025·Announced 2024-10-16

Inspire Respiratory Sensing Lead Model 4340 Serial Number Label Mismatch

FDA recall of 152 Inspire Model 4340 Respiratory Sensing Lead units due to a labeling error—the serial number printed on the product box does not match the actual serial number of the device inside.

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: This is a FDA Class II labeling error with no reported illnesses, injuries, or adverse events. The hazard is a documentation issue—a mismatch between the box label and device serial number—rather than a physical safety risk, consistent with the rubric's classification of minor labeling errors as Moderate severity.

Plain-English summary

The Inspire Model 4340 Respiratory Sensing Lead is a component of the Inspire Upper Airway Stimulation (UAS) system used to treat sleep apnea. The FDA has issued a Class II recall of 152 units of this device due to a labeling error.

The issue is a mismatch between the serial number printed on the product's shelf box and the actual serial number of the respiratory sensing lead contained within the box. This discrepancy affects device identification and tracking. The affected units were distributed worldwide, including the United States, Belgium, Switzerland, Germany, United Kingdom, Netherlands, and Singapore.

Affected parties should verify the serial numbers on their device boxes against the list of affected serial numbers provided by Inspire Medical Systems Inc. If a device's serial number matches one on the recall list, contact Inspire Medical Systems Inc. immediately for instructions on replacement or further guidance. Healthcare facilities and implanting physicians should not use affected devices until they have confirmed their serial numbers and received manufacturer guidance.

The recalled product

Product: Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Manufacturer: Inspire Medical Systems Inc.
Category: Medical Device — Respiratory Device
Hazard: mis-labeling
Affected units: 152

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)

D59550
D59543
D59541
D59542
D59528
D59526
D59534
D59521
D59477
D59519
D59515
D59516
D59489
D59514
D59512
D59510
D59509
D59547
D59549
D59505

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Inspire Medical Systems Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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
Severe
Inspire Model 3028 Implantable Pulse Generator Manufacturing Defect
FDA (Devices) · 2024-07-03
Moderate
Inspire II Implantable Pulse Generator Recalled for Incorrect Use-By Date
FDA (Devices) · 2018-09-12

Same hazard · mis labeling