DeVilbiss Healthcare LLC: Medical Device Recall in 2022 - (Recall #: Z-0229-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 19, 2022

Date Posted: November 23, 2022

Recall Number: Z-0229-2023

Event ID: 90950

Reason for Recall:

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

Status: Ongoing

Product Quantity: 48 units

Code Information:

UDI: 00885304022237 S/N: New Sales D22829087DS D22829097DS D22829092DS D22829086DS D22829156DS D22901205DS D22901207DS D22829099DS D22829161DS D22901203DS D22829157DS D22829159DS D22901204DS D22901201DS D22829096DS D22826095DS D22826079DS D22826091DS D22826086DS S/N: Repair D22829087DS D22829097DS D22829092DS D22829086DS D22829156DS D22901205DS D22901207DS D22829099DS D22829161DS D22901203DS D22829157DS D22829159DS D22901204DS D22901201DS D22829096DS D22826095DS D22826079DS D22826091DS D22826086DS

Distribution Pattern:

US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.

Voluntary or Mandated:

Voluntary: Firm initiated