Class II U.S. Food and Drug Administration

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire recall: Products are labeled with incorrect Use By Date

Recall published 4 months ago

Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

The hazard: Lead or heavy metal content

This product was recalled over lead content above the federal limit, which is a chronic-exposure hazard rather than a one-off emergency.

What the notice says: Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

Why it matters: The product exceeds the federal limit on lead or another heavy metal. Lead harms the developing brain, and the damage builds quietly from small repeated exposures rather than arriving as a single dramatic poisoning.

Symptoms and when to call a doctor

The CDC states there is no known safe level of lead in a child’s blood, and that most children with elevated levels show no symptoms at all. That is why a blood lead test, not a symptom check, is the way to find out. Ask your paediatrician about testing if a child has handled, mouthed or worn the product regularly. Where symptoms do appear they are non-specific — irritability, poor appetite, stomach pain, tiredness, constipation or a drop in attention and learning.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2516-2026
Published
June 24, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Inspire Medical Systems Inc.
Product type
Medical devices
Units affected
10 impacted units
Distribution
Nationwide
Made in
United States
Lot / code info
Lot Code: Model 4063 (USA only lead); UDI-DI [4063] 10855728005793; Inspire part number [4063] 900-013-001; serial numbers D53393, D61104 Model 4063 (Global lead); UDI-DI [4063] 10810098650295, Inspire part number [4063] 900-013-003; serial numbers D89539, D89540, D89543, D89559, D89563, D89564, D89577, D8959
UPC codes
10855728005793, 10810098650295

Products covered by this recall

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10855728005793
  • 10810098650295

Model or item number

On the rating label, the box or the instruction sheet.

  • 4063

Serial number

On the rating plate, often next to the date of manufacture.

  • D53393
  • D89539
  • D89540
  • D89543
  • D89559
  • D89563

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Lead

Inspire Medical Systems Inc. — This product was recalled over lead content above the federal limit, which is a chronic-exposure hazard rather than a one-off emergency.

  1. Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.
  2. Ask your paediatrician whether a blood lead test is warranted, especially for a child under six or anyone pregnant.
  3. Do not sand, scrape, burn or break the item up; that turns a contained hazard into dust you can breathe.
  4. Follow the remedy on this page — lead recalls almost always carry a full refund.

Claiming your refund, repair or replacement

The recalling company decides the remedy and funds it. You should never pay for a recall repair or for return shipping.

  • Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.
  • Have the model number, the date code and your photos ready. Many companies issue store credit by default — ask for cash or a card reversal if you would rather have it.
  • No receipt? Say so. Recall refunds are routinely paid without proof of purchase, because the hazard is what triggers the obligation.
  • If you bought it from a retailer rather than the brand, try both. Target, Walmart and Amazon often refund recalled goods from the order history.

Company contact: Inspire Medical Systems Inc. — 5500 Wayzata Blvd Ste 1600, Golden Valley, MN, 55416-1237

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Inspire Medical Systems Inc. medical devices recalled?

Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery. Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10855728005793, 10810098650295; model number 4063. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.

Can I get my money back?

Use the company contact on this page first. Most firms run a dedicated recall page with a claim form that is far quicker than their main support line.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls