Inspire Medical Systems recalls Inspire Model 4063 Stimulation Lead due to labeling error between shelf box serial number and lead serial number. Affected units have specific serial numbers listed in the recall.
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 the Inspire Model 4063 Stimulation Lead component of their Upper Airway Stimulation system because of a labeling error. This mismatch between the shelf box serial number label and the actual lead serial number could lead to confusion during device identification.
The recall is for a labeling error where the serial number on the shelf box does not match the serial number of the lead inside the box. This mismatch could cause confusion when identifying the correct device part, but it does not pose a direct safety risk.
Patients using the Inspire Upper Airway Stimulation system with the specific Model 4063 Stimulation Lead serial numbers listed in the recall are affected. The risk is low as the issue is a labeling error, not a safety hazard.
Check if your Inspire Model 4063 Stimulation Lead has a serial number listed in the provided list of serial numbers (e.g., T52648, T52644, etc.). The product is part of the Inspire Upper Airway Stimulation system.
Verify if your lead's serial number matches any in the list provided in the recall.
Inspire Medical Systems is recalling the Inspire Model 4063 Stimulation Lead due to a labeling error where the shelf box serial number label does not match the actual lead serial number.
Check if your Inspire Model 4063 Stimulation Lead has a serial number listed in the detailed list of serial numbers provided in the recall.
The recall does not require immediate action beyond checking if your serial number matches the list. No repair or replacement is needed.
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-0041-2025 — Inspire Medical Systems Inspire Medical Systems Hello, I own a Inspire Medical Systems that is covered by recall Z-0041-2025 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.
