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.
What this means for you
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.
- Hazard
- mis-labeling
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.
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