Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

DeVilbiss Model DV5x Series CPAP units. For use in treating Recalled by DeVilbiss Healthcare LLC Due to A limited number of DV5x Series CPAP units...

Date: May 13, 2014
Company: DeVilbiss Healthcare LLC
Status: Terminated
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

DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments.

Quantity: 1809

Why Was This Recalled?

A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST".

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 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