Inspire Medical Systems recalls Model 4340 Respiratory Sensing Lead due to labeling error between box serial and actual serial numbers. Affected units have specific serial numbers listed. No action needed per recall details.
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Inspire Medical Systems is recalling Model 4340 Respiratory Sensing Leads because there's a mismatch between the serial number on the box and the actual serial number of the lead. This labeling error could lead to incorrect identification of the device, but it does not pose a safety risk to users.
The recall is due to a labeling error where the serial number on the product box does not match the actual serial number of the lead. This mismatch could cause confusion during device identification, but it does not involve any safety hazard or risk of injury.
Patients using the Inspire Upper Airway Stimulation (UAS) system with the Model 4340 Respiratory Sensing Lead are likely affected. Those who have the specific serial numbers listed in the recall are at risk of receiving the wrong device.
Check if your Inspire Model 4340 Respiratory Sensing Lead has a serial number from the list provided in the recall (e.g., D59544, D59550, etc.). The product is part of the Inspire UAS system.
Verify if your lead has a serial number from the list of affected serial numbers provided in the recall.
No, the recall is for labeling error only and does not pose a safety risk. The device itself is safe to use.
No action is required. The recall is informational only and does not affect device safety.
The affected serial numbers are listed in the recall: D59544, D59550, D59543, and many others as detailed in the record.
We’ve drafted a message you can send Inspire Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0040-2025 — Inspire Medical Systems Inspire Medical Systems Hello, I own a Inspire Medical Systems that is covered by recall Z-0040-2025 from Inspire Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
