Inovo Single Luman Conserver Product Usage: This device is intended… — Class II medical device recall Z-2099-2019
Terminated recall by Inovo, Inc, reported 2019-08-07, distributed nationwide. The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.
| Recall number | Z-2099-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inovo, Inc, Lehigh Acres, FL, United States |
| Recall initiated | 2019-04-26 |
| Classified | 2019-07-29 |
| Reported by FDA | 2019-08-07 |
| Terminated | 2021-04-02 |
| Distributed | Nationwide (US) |
| Quantity | 690 |
| Reason classes | packaging |
| Model numbers | C0019385, C0019386, C0019387, C0019388, C0019389, C0019390, C0019391, C0019392, C0019393, C0019394, C0019395, C0019396, C0019397, C0019398, C0019399, C0019400, C0019401, C0019402, C0019403, C0019404, C0019405, C0019406, C0019407, C0019408, C0019409 and 475 more |
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 for recall
The pressure gauge (manometer) may dislodge from the threaded insertion/mount, creating a leak.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2099-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.