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Lower risk Medical device recall · FDA · Published June 12, 2018

Inspire II IPG Recall: Incorrect Use-By Date on Labels

Inspire Medical Systems recalls Inspire II Model 3024 IPGs due to incorrect use-by dates (2018-01-14) on patient file labels. Check your device registration.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2969-2018Medical deviceInspire Medical Systems ›
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Contact the company

Recalling firmInspire Medical Systems Inc.9700 63rd Ave N Ste 200 · Maple Grove, MN 55369-6202
✎ GovInfoNow plain-language explainer

Inspire Medical Systems Inc. is recalling the Inspire II Model 3024 Implantable Pulse Generator because the device registration/patient file labels contain an incorrect use-by date of 2018-01-14. This error appears in the literature packet found with the sterile tray or IPG, specifically on the large label sticker set. The recall affects 93 devices distributed nationwide. Read more at govinfonow.com/recall/70853-inspire-ii-model-3024-ipg-recall-incorrect-use-by-date.

Source Summary by GovInfoNow · govinfonow.com/recall/70853-inspire-ii-model-3024-ipg-recall-incorrect-use-by-date · Updated October 13, 2026 · FDA enforcement record: FDA #Z-2969-2018

Cite this page

“Inspire II IPG Recall: Incorrect Use-By Date on Labels.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/70853-inspire-ii-model-3024-ipg-recall-incorrect-use-by-date. Based on FDA recall #Z-2969-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2969-2018%22&limit=1).

The FDA announced on June 12, 2018, that Inspire Medical Systems Inc. is recalling Inspire II Model 3024 Implantable Pulse Generators due to incorrect use-by dates on device registration labels. The agency issued recall number Z-2969-2018 for the Class II voluntary recall.

How to tell if you have it

  • Brand: Inspire Medical Systems
  • Product: Inspire II Model 3024 Implantable Pulse Generator (IPG)
  • Part #: 900-003-020
  • UDI: 10855728005434
  • Affected serial numbers in stock: NCR202227H, NCR202230H, NCR202238H, NCR202244H, NCR202245H, NCR202246H, NCR202247H, NCR202252H, NCR202253H, NCR202254H, NCR202255H, NCR202259H, NCR202260H, NCR202261H, NCR202264H, NCR202266H, NCR202267H, NCR202268H, NCR202269H, NCR202270H, NCR202272H, NCR202273H, NCR202274H, NCR202275H, NCR202276H, NCR202277H, NCR202278H, NCR202279H, NCR202281H, NCR202282H, NCR202283H, NCR202284H, NCR202285H, NCR202287H, NCR202294H, NCR202306H, NCR202307H, NCR202314H, NCR202315H, NCR202317H, NCR202320H, NCR202324H, NCR202325H, NCR202328H, NCR202336H, NCR202337H, NCR202338H, NCR202339H, NCR202466H, and NCR202467H
  • Implanted serial numbers: NCR202231H, NCR202233H, NCR202234H, NCR202236H, NCR202237H, NCR202239H, NCR202241H, NCR202242H, NCR202249H, NCR202250H, NCR202251H, NCR202256H, NCR202257H, NCR202258H, NCR202262H, NCR202265H, NCR202286H, NCR202291H, NCR202293H, NCR202296H, NCR202297H, NCR202300H, NCR202301H, NCR202302H, NCR202303H, NCR202304H, NCR202309H, NCR202310H, NCR202311H, NCR202312H, NCR202313H, NCR202318H, NCR202321H, NCR202322H, NCR202323H, NCR202326H, NCR202327H, NCR202329H, NCR202330H, NCR202331H, NCR202332H, NCR202333H, and NCR202334H
  • Quantity: 93 devices
  • Distribution: US Nationwide in AL, AZ, CA, FL, GA, IL, KY, MA, MI, MN, MS, NY, OH, PA, TN, TX, VA, WA, and WI

The hazard

The recall addresses incorrect use-by dates on the device registration/patient file labels. The incorrect Use By Date of 2018-01-14 appears in the literature packet included with the sterile tray/IPG. This error affects the 3 large label sticker set within the device registration label set.

Context

GovInfoNow's records show Inspire Medical Systems Inc. has 3 other recalls on record since 2024-05-16. On 2026-05-11, the company recalled an Inspire Stimulation Lead due to incorrect use-by dates extending shelf life risk. Other recent recalls of similar products include Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation (2026-05-13), Medtronic Pocket Adaptor Kits with Incorrect Use-By Dates Recalled (2026-05-13), and Urinary Clean Catch Kit Recalled Due to Incorrect Expiration Date (2026-07-09).

How to tell if you have this one

Check the literature packet in the box with your sterile tray or IPG for the device registration label set. Look for large label stickers showing an incorrect use-by date of 2018-01-14. Affected serial numbers include NCR202227H through NCR202334H (specifically listed in stock and implanted lists).

  • Brand
    Inspire Medical Systems
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Your Device Labels

    Review the device registration label set in your literature packet for the incorrect use-by date of 2018-01-14.

  2. Contact Your Doctor

    If you have one of the affected serial numbers, consult your healthcare provider for further instructions on how to proceed with the correction.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 19 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, KY, MA, MI, MN, MS, NY, OH, PA, TN, TX, VA, WA, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Jun 12, 201812. FDA classified it Class II: Sep 4, 201823. Published in FDA’s Enforcement Report: Sep 12, 201834. FDA terminated the recall: May 21, 2019420182019
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-2969-2018 (June 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2969-2018 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA