Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Gas Module 3 monitoring spirometer Recalled by Mindray DS USA, Inc. dba Mindray North America Due to The firm made multiple changes to the product...
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
Gas Module 3 monitoring spirometer, Part Number: 115-030108-00 Product Usage: The Gas Module 3 is an accessory device designed to monitor airway gases during anesthesia and/or assisted respiration. Monitored gases includes O2, CO2, N2O and anesthetic agents Halothane, Isoflurane, Sevoflurane, Desflurane and Enflurane. It is intended for use in a fixed location such as the operating room or intensive care unit. The Gas Module 3 is compatible with Mindray patient monitors which display the gas analysis results through the use of a proprietary communication protocol.
Quantity: 1719
Why Was This Recalled?
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mindray DS USA, Inc. dba Mindray North America
Mindray DS USA, Inc. dba Mindray North America has 39 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report