🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: September 19, 2022 DeVilbiss Healthcare Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
DeVilbiss Healthcare LLC
Reason for Recall:
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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:

Distributed in: US, CA, FL, OH, MI, MN, NY, PA, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0229-2023

Related Recalls

DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q

DeVilbiss Healthcare

Class I - Dangerous

The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.

Nov 18, 2022 Other Medical Devices Nationwide View Details →