CLASS II Device recall · Reported 31 Jan 2018 · FDA Enforcement Report
Pure Oxygen Concentrator, Chad Drive recalled by Inovo
Inovo is recalling Pure Oxygen Concentrator, Chad Drive. The recall was initiated on 9 Oct 2017 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-0407-2018
- FDA event ID
- 78883
- Recalling firm
- Inovo, Lehigh Acres, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Oct 2017
- FDA classified
- 24 Jan 2018
- Reported
- 31 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- CPAP & Ventilators
Timeline
| 9 Oct 2017 | Recall initiated by company | |
| 24 Jan 2018 | Classified by FDA | +107 days |
| 31 Jan 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
Where it was distributed
worldwide
Questions about this recall
Why was it recalled?
Post-market surveillance for Pure Stationary Oxygen Concentrators model CHSOOO and CHSOOOS demonstrate an aggregate complaint/service rate greater than 35% for low oxygen purity (output oxygen below the published specification).
Which lots are affected?
UDI #(s): 00814470020013 (model CHSOOO) and 00814470020006 (model CHSOOOS): All serial numbers
Where was it sold?
worldwide
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 Inovo
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|---|---|---|---|---|---|
| Device | CLASS II | Single Luman Conserver recalled by Inovo | Inovo | Packaging Defects | Nationwide |
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| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |