FDA Device recall Z-2099-2019

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

FDA Device
Class II
terminated
Published 2019-08-07

On 2019-08-07 the FDA classified a Class II recall of Inovo Single Luman Conserver Product Usage: This device is intended to regulate the flow of oxygen from an oxygen tank and only deliver oxy… by Inovo, citing the pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2099-2019
Classification	Class II
Status	terminated
Initiated	2019-04-26
Published	2019-08-07
Last updated	2026-09-13 11:55 UTC
Company	Inovo
Distribution	US

Product

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.

Reason

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

Identifiers

code_info	SERIAL NUMBERS BY MODELS: C0019802 IN6505-L-Blue C0019803 IN6505-L-Blue C0019804 IN6505-L-Blue C0019805 IN6505-L-Bl… 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 IN65

code_info

SERIAL NUMBERS BY MODELS: C0019802 IN6505-L-Blue C0019803 IN6505-L-Blue C0019804 IN6505-L-Blue C0019805 IN6505-L-Bl…

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 IN65

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2099-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.