Class II — Potential Health Hazard

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

Mindray DS USA Inc. Recalled by Mindray DS USA, Inc. dba Mindray North America Due to Mindray has identified a potential leakage issue with...

Date: June 23, 2016
Company: Mindray DS USA, Inc. dba Mindray North America
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 Mindray DS USA, Inc. dba Mindray North America directly.

Affected Products

Mindray DS USA Inc., Passport Series Patient Monitor intended for monitoring, displaying, reviewing, alarming, and transferring of multiple physiological parameters including ECG (3-lead, 5-lead or 12-lead selectable, arrythmia detection, ST segment analysis, and heart rate (HR), Respiration rate.

Quantity: 360 units

Why Was This Recalled?

Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mindray DS USA, Inc. dba Mindray North America

Mindray DS USA, Inc. dba Mindray North America has 39 total recalls tracked by RecallDetector.

Related Recalls

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