🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: November 18, 2022 DeVilbiss Healthcare Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots
  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:
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.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0724-2023

Related Recalls