CLASS II Device recall · Reported 12 Sep 2018 · FDA Enforcement Report
Inspire II recalled by Inspire Medical Systems
Inspire Medical Systems is recalling Inspire II, distributed nationwide in the US. The recall was initiated on 12 Jun 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2969-2018
- FDA event ID
- 80372
- Recalling firm
- Inspire Medical Systems, Maple Grove, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2018
- FDA classified
- 4 Sep 2018
- Reported
- 12 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 12 Jun 2018 | Recall initiated by company | |
| 4 Sep 2018 | Classified by FDA | +84 days |
| 12 Sep 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect use-by date on the device registration/patient file labels.
Product as listed by the FDA
Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaFloridaGeorgiaIllinoisKentuckyMassachusettsMichiganMinnesotaMississippiNew YorkOhioPennsylvaniaTennesseeTexasVirginiaWashingtonWisconsin
Questions about this recall
Why was it recalled?
Incorrect use-by date on the device registration/patient file labels.
Which lots are affected?
UDI 10855728005434. The incorrect Use By Date of 2018-01-14 can be found in the literature packet that is in the box with the sterile tray/IPG. The literature packet contains the product/patient manuals, device registration form, and the device registration label set. The 3 large label sticker set with the device registration label set contains the incorrect use-by date.. Affected serial numbers in the customer's 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; Serial numbers implanted: 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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Inspire Medical Systems
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Inspire Respiratory Sensing Lead recalled by Inspire Medical Systems | Inspire Medical Systems | Potency & Assay | Nationwide |
| Device | CLASS II | Inspire stimulation Lead recalled by Inspire Medical Systems | Inspire Medical Systems | Potency & Assay | Nationwide |
| Device | CLASS II | Inspire Model 4063 Stimulation Lead, component of the Inspire Upper recalled | Inspire Medical Systems | Labeling Errors | Nationwide |
| Device | CLASS II | Inspire Model 4340 Respiratory Sensing Lead recalled | Inspire Medical Systems | Labeling Errors | Nationwide |
| Device | CLASS I | Inspire Model 3028, IV Implantable Pulse Generator recalled | Inspire Medical Systems | Packaging Defects | Nationwide |
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