125 Series iGO2 Portable Oxygen Concentrator Recalled for Unapproved Adhesive
DeVilbiss is recalling 125 series iGO2 oxygen concentrators due to an unapproved adhesive in the accumulator tank, which is part of the oxygen delivery system. Affected units were distributed in eight U.S. states and Canada.
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: FDA Class II recall involving a manufacturing defect in a critical oxygen delivery component. No illnesses or injuries have been reported, but the unapproved adhesive in the accumulator tank poses a risk of device malfunction in patients dependent on this therapy.
Plain-English summary
DeVilbiss Healthcare LLC has recalled the 125 series iGO2 Portable Oxygen Concentrator (Models 125D and 125D-XB) due to a manufacturing defect. An unapproved adhesive was used in the accumulator tank sub-assembly, which is a critical part of the patient gas pathway that delivers supplemental oxygen to patients.
Approximately 48 units were distributed in the United States (California, Florida, Ohio, Michigan, Minnesota, New York, Pennsylvania, and Texas) and Canada.
The use of an unapproved adhesive in a critical component raises concerns about potential device malfunction. Patients currently using affected models should contact DeVilbiss Healthcare LLC immediately to discuss repair or replacement options. Do not stop using the device without consulting your healthcare provider, as oxygen therapy interruption could pose serious health risks.
The recalled product
- Product
- 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB
- Manufacturer
- DeVilbiss Healthcare LLC
- Category
- Medical Device — Respiratory
- Affected units
- 48
Distribution
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