Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of Recalled by DeVilbiss Healthcare LLC Due to An unapproved adhesive used to manufacture the accumulator...

Date: September 19, 2022
Company: DeVilbiss Healthcare LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact DeVilbiss Healthcare LLC directly.

Affected Products

125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB

Quantity: 48 units

Why Was This Recalled?

An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)

Where Was This Sold?

This product was distributed to 8 states: CA, FL, MI, MN, NY, OH, PA, TX

Affected (8 states)Not affected

About DeVilbiss Healthcare LLC

DeVilbiss Healthcare LLC has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report