Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray Recalled by Mindray DS USA, Inc. d.b.a. Mindray North America Due to Mindray has identified the potential for a system...

Date: August 13, 2012
Company: Mindray DS USA, Inc. d.b.a. 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. d.b.a. Mindray North America directly.

Affected Products

Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's ventilation.

Quantity: 346 units (311 US - 35 Foreign)

Why Was This Recalled?

Mindray has identified the potential for a system leak resulting an issue related to the carbon dioxide absorber canister gasket on A3/A5 Anesthesia Delivery Systems. A potential system leak resulting from the canister gasket will likely present itself during the Automatic Circuit Leak and Compliance Test performed at startup and the Manual Leak Test recommended to be performed before each case.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Mindray DS USA, Inc. d.b.a. Mindray North America

Mindray DS USA, Inc. d.b.a. Mindray North America has 9 total recalls tracked by RecallDetector.

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