Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an…
Medical device recall Z-2099-2019. Published in FDA’s Enforcement Report on Aug 7, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 7, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 13 states named
- 690 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Inovo Single Luman Conserver Product Usage: This 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.
690, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
SERIAL NUMBERS BY MODELS: 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…
Every code shown here, 1,990 characters
SERIAL NUMBERS BY MODELS: 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 C0019818 IN6505-L-Blue C0019832 IN6505-L-Blue C0019836 IN6505-L-Blue C0019837 IN6505-L-Blue C0019838 IN6505-L-Blue C0019873 IN6505-L-Blue C0019883 IN6505-L-Blue C0019892 IN6505-L-Blue C0019896 IN6505-L-Blue C0019903 IN6505-L-Blue C0019909 IN6505-L-Blue C0019916 IN6505-L-Blue C0020405 IN6505-L-Blue C0020416 IN6505-L-Blue C0020417 IN6505-L-Blue C0020431 IN6505-L-Blue C0020432 IN6505-L-Blue C0019890 IN6505-L-Blue C0019891 IN6505-L-Blue C0019912 IN6505-L-Blue C0019915 IN6505-L-Blue C0020407 IN6505-L-Blue C0020410 IN6505-L-Blue C0020414 IN6505-L-Blue C0020418 IN6505-L-Blue C0019854 IN6505-L-Blue C0020406 IN6505-L-Blue C0020411 IN6505-L-Blue C0019864 IN6505-L-Blue C0019868 IN6505-L-Blue C0019877 IN6505-L-Blue C0019879 IN6505-L-Blue C0019882 IN6505-L-Blue C0019886 IN6505-L-Blue C0020419 IN6505-L-Blue C0020423 IN6505-L-Blue C0020426 IN6505-L-Blue C0020429 IN6505-L-Blue C0020430 IN6505-L-Blue C0020433 IN6505-L-Blue C0019853 IN6505-L-Blue C0019867 IN6505-L-Blue C0019870 IN6505-L-Blue C0019876 IN6505-L-Blue C0019880 IN6505-L-Blue C0019888 IN6505-L-Blue C0019801 IN6505-L-Blue C0019817 IN6505-L-Blue C0019829 IN6505-L-Blue C0019830 IN6505-L-Blue C0019835 IN6505-L-Blue C0020408 IN6505-L-Blue C0020409 IN6505-L-Blue C0020412 IN6505-L-Blue C0020413 IN6505-L-Blue C0020415…
FDA’s list runs to 13,074 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide Distribution - AZ, CO, FL, GA, IL, LA, MI, MO, MT, NY, SC, TX, and UT
The states and territories these words name
13 states and territories.
Every one of them
- Arizona
- Colorado
- Florida
- Georgia
- Illinois
- Louisiana
- Michigan
- Missouri
- Montana
- New York
- South Carolina
- Texas
- Utah
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 26, 2019.
- FDA classified it on Jul 29, 2019.
- FDA’s Enforcement Report published it on Aug 7, 2019.
- FDA terminated it on Apr 2, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Inovo, Inc, of Lehigh Acres, FL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 13,074 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.