Reported Aug 7, 2019 · Terminated

Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank…

Inovo, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Inovo, Inc · 401 Leonard Blvd N · Lehigh Acres, FL · 33971-6302

Is this the product you have?

  • Inovo
  • Single Luman Conserver Product UsageThis device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxygen as the patient inhales, resulting in greater efficiency and cost saving ratios
Lot codes and dates
  • SERIAL NUMBERS BY MODELS

    1,368 of 1,368 codes

    • C0019802
    • IN6505-L-Blue
    • C0019803
    • IN6505-L-Blue
    • C0019804
    • IN6505-L-Blue
    • C0019805
    • IN6505-L-Blue
    • C0019806
    • IN6505-L-Blue
    • C0019808
    • IN6505-L-Blue
    • C0019820
    • IN6505-L-Blue
    • C0019825
    • IN6505-L-Blue
    • C0019826
    • IN6505-L-Blue
    • C0019827
    • IN6505-L-Blue
    • C0019828
    • IN6505-L-Blue
    • C0019831
    • IN6505-L-Blue
    • C0019833
    • IN6505-L-Blue
    • C0019834
    • IN6505-L-Blue
    • C0019874
    • IN6505-L-Blue
    • C0019894
    • IN6505-L-Blue
    • C0019895
    • IN6505-L-Blue
    • C0019899
    • IN6505-L-Blue
    • C0019917
    • IN6505-L-Blue
    • C0019918
    • IN6505-L-Blue
    • C0019884
    • IN6505-L-Blue
    • C0019889
    • IN6505-L-Blue
    • C0019893
    • IN6505-L-Blue
    • C0019897
    • IN6505-L-Blue
    • C0019910
    • IN6505-L-Blue
    • C0019911
    • IN6505-L-Blue
    • C0019913
    • IN6505-L-Blue
    • C0019914
    • IN6505-L-Blue
    • C0020421
    • IN6505-L-Blue
    • C0019807
    • IN6505-L-Blue
    and C0020216 R6505-L
Amount recalled
690

Where it was sold

Why it was recalled

The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 2, 2021 · Data as of Sep 19, 4:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.