Inovo CHAD Drive Oxygen Concentrators Recalled for Low Purity
Inovo, Inc. is recalling CHAD Drive oxygen concentrators because post-market surveillance found a high rate of low oxygen purity complaints.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device failing to meet oxygen purity specifications, which poses a risk of harm to patients relying on the device, but the source text does not report specific injuries or hospitalizations, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Inovo, Inc. is recalling the CHAD Drive Pure Oxygen Concentrators, Models CH5000 and CH5000S. The recall involves 13,140 units that were distributed worldwide. The affected units are identified by UDI numbers 00814470020013 (model CH5000) and 00814470020006 (model CH5000S), covering all serial numbers.
The recall was initiated because post-market surveillance demonstrated an aggregate complaint and service rate greater than 35% for low oxygen purity. Specifically, the devices were found to output oxygen below the published specification. This issue is classified as an FDA Class II recall.
Consumers with these devices should contact Inovo, Inc. for instructions on how to resolve the issue. The source text does not specify a particular action such as stopping use or returning the device, but users should follow the manufacturer's guidance.
The recalled product
- Product
- PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
- Manufacturer
- Inovo, Inc
- Hazard
- Affected units
- 13,140
Distribution
Distribution scope not specified by the agency.
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