Mindray Gas Module 3 monitoring spirometer recalled for regulatory changes
Mindray DS USA is recalling 1,719 Gas Module 3 monitoring spirometers because the firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The source text cites regulatory changes requiring a new 510(k) notification rather than a specific safety hazard or reported injury.
Plain-English summary
Mindray DS USA, Inc. dba Mindray North America is recalling 1,719 units of the Gas Module 3 monitoring spirometer, Part Number 115-030108-00. This accessory device is designed to monitor airway gases, including O2, CO2, N2O, and various anesthetic agents, during anesthesia or assisted respiration in fixed locations such as operating rooms or intensive care units.
The recall was initiated because the firm made multiple changes to the product that required the submission of a new 510(k) premarket notification to the FDA. The affected units were purchased between February 14, 2008, and October 2015. The devices were distributed nationwide in the United States, including Puerto Rico, and to 30 foreign consignees worldwide.
The source text does not specify any reported injuries, illnesses, or specific hazards associated with the product changes. Users of this device should contact the recalling firm for further instructions regarding the recall.
The recalled product
- Product
- 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…
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Affected units
- 1,719
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All Gas Modules 3 with Part Number 115-030108-00 purchased between February 14
- 2008 and October 2015.
Distribution
Related recalls
Same manufacturer · Mindray DS USA, Inc. dba Mindray North America
See all →- HighCentral monitoring workstations recalled over audio failure and screen freezing
FDA (Devices) · 2025-12-24
- HighAnesthesia vaporizers recalled over the potential for anesthesia leakage
FDA (Devices) · 2025-12-03
- HighIsoflurane vaporizers recalled over the potential for anesthesia leakage
FDA (Devices) · 2025-12-03
- HighPatient monitors recalled over potential activation of an abnormal alarm pause
FDA (Devices) · 2025-10-01
- HighSevoflurane Vaporizer for A9 Anesthesia System Recalled for Output Malfunction
FDA (Devices) · 2024-09-11
Same hazard · regulatory non compliance
See all →- ModerateLimitless Cryo Spa LLC Recalls Glypto Devices for Lack of 510(k) Clearance
FDA (Devices) · 2026-10-14
- SevereSempio Recalls Ready-to-Eat Chicken Stew Imported Without Reinspection
USDA FSIS · 2026-09-25
- ModerateMedline Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- SevereMedline polycarbonate syringes recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- ModerateMedline 10mL Polycarbonate Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
Similar recalls
- ModerateMindray Recalls DPM 6 and 7 Patient Monitors for Software Limitations
FDA (Devices) · 2012-12-19
- ModerateMindray Passport Series Patient Monitor CO2 Module Recall
FDA (Devices) · 2016-08-24
- HighMindray Recalls V Series Patient Monitors Due to Software Anomalies
FDA (Devices) · 2012-09-05
- SevereMindray A3 Anesthesia Delivery System Recalled for Potential System Leak
FDA (Devices) · 2012-11-28
- ModerateMindray Accutorr 3 Vital Signs Monitor Recalled for Software Features
FDA (Devices) · 2019-11-06
- HighMindray A-Series Anesthesia Delivery System Software Recall
FDA (Devices) · 2018-03-14