The Recall Desk

Manufacturer

Mindray DS USA, Inc. dba Mindray North America

39 recalls in our database name Mindray DS USA, Inc. dba Mindray North America as the manufacturing or recalling firm.

What the numbers show

Total
39
Critical
0
Severe
1
Most recent
2025-12-24

Of the 39 recalls from Mindray DS USA, Inc. dba Mindray North America we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 39

  • HighFDA (Devices)·Z-0920-2026·2025-12-24

    Central monitoring workstations recalled over audio failure and screen freezing

    Mindray is recalling 906 BeneVision Distributed Monitoring System units because a specific workstation hardware configuration may experience audio playback failure or screen freezing.

    Product
    Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 115-050935-00 and E115-050935-00. Software Version: Audio Driver version 6.0.9484.1 HP Pro Mini 400 G9 Desktop PC with Realtek HD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0720-2026·2025-12-03

    Anesthesia vaporizers recalled over the potential for anesthesia leakage

    Mindray is recalling 148 Sevoflurane V90 Electronic Vaporizers used with the A9 Anesthesia System over the potential for anesthesia leakage.

    Product
    Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00. Product Description: Th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2026·2025-12-03

    Isoflurane vaporizers recalled over the potential for anesthesia leakage

    Mindray is recalling 54 Isoflurane V90 Electronic Vaporizers used with the A9 Anesthesia System over the potential for anesthesia leakage.

    Product
    Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Safety Filling adapter), Part Number E115-066758-00. Product Description: The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2622-2025·2025-10-01

    Patient monitors recalled over potential activation of an abnormal alarm pause

    BeneVision N1 Patient Monitors are recalled because of the potential for activation of an abnormal alarm pause. 2,278 units are affected.

    Product
    BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2952-2024·2024-09-11

    Desflurane anesthesia vaporizer recalled for possible excessive anesthetic output

    Mindray's Desflurane E_Vap vaporizer may deliver anesthetic at higher concentrations than set due to an incomplete seal. Patients could inhale excessive anesthetic, potentially causing dizziness, drowsiness, and in severe cases, neurological effects.

    Product
    Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number115-066759-00
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2951-2024·2024-09-11

    Anesthesia System Vaporizer Adapter Recalled for Potential Anesthetic Overdose

    Mindray's Isoflurane E_Vap adapter for the A9 Anesthesia System is recalled due to a seal defect that may cause higher-than-intended anesthetic concentration delivery. Twenty-four units were distributed to eight U.S. states and Canada.

    Product
    Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: Part Number 115-066758-00
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2950-2024·2024-09-11

    Anesthesia Vaporizer Adapter May Deliver Excessive Anesthetic Concentration

    Sevoflurane vaporizer adapters used with Mindray A9 anesthesia systems may deliver higher-than-set anesthetic concentrations due to incomplete sealing. Patients could inhale excessive anesthetic, potentially causing drowsiness, vertigo, or in severe cases, neurological effects.

    Product
    Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number: 115-066756-00
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2949-2024·2024-09-11

    Sevoflurane Vaporizer for A9 Anesthesia System Recalled for Output Malfunction

    Mindray recalled 2 Sevoflurane E_Vap vaporizers used in A9 Anesthesia Systems due to a component defect causing excessive anesthetic output. The defect risks patient anesthetic overdose with potential neurological effects including post-operative vertigo and drowsiness.

    Product
    Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provide the vapor of an anesthetic agent with controllable concentration to an A9 anesthesia system. Part Number 115-066755-00
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2108-2021·2021-07-28

    Mindray battery cradle may prevent monitor from powering on

    Mindray is recalling the 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 and TM80 Telepack physiological monitors. The cradle may prevent the monitor from powering on. Approximately 804 units were distributed in the US and Canada.

    Product
    3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1254-2021·2021-03-24

    Mindray BeneVision Distributed Monitoring System Recalled for Intermittent Freezes

    Mindray is recalling 1,938 BeneVision Distributed Monitoring Systems because they may intermittently freeze, causing telemetry data to stop communicating to the central system.

    Product
    Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1330-2020·2020-02-26

    Mindray DP-30 Ultrasound Systems Recalled for Incorrect Needle-Guide Display

    Mindray is recalling 53 DP-30 ultrasound systems and 18 USB drives because the devices display an incorrect needle-guide bracket when used with a specific transducer.

    Product
    DP-30 Digital Ultrasonic Diagnostic Imaging System, Part No. 1155E-PA00004 - Product Usage: The Digital Ultrasonic Diagnostic Imaging System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small org
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2020·2020-02-05

    Mindray ABS800 Chemistry Analyzer Gas Spring Recall

    Mindray is recalling six ABS800 Chemistry Analyzers due to a potential gas spring failure that poses a low risk of impact injury to users.

    Product
    ABS800 Chemistry Analyzer Part Number BA81F-PA00001, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0920-2020·2020-02-05

    Mindray BA-800M Chemistry Analyzer Recalled for Gas Spring Failure Risk

    Mindray is recalling seven BA-800M Chemistry Analyzers because a gas spring on the protective cover may fail, posing a low risk of impact injury to users.

    Product
    BA-800M Chemistry Analyzer Part Numbers BA81E-PA00002 and BA81E-PA00003, Containing Gas spring YQ-8/18-90-272-180N (Material Code M6T-010001--- (front spring)) and Gas spring YQ6/15-84-235(B-B)-80N (033-000090-00 (rear spring))
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0236-2020·2019-11-06

    Mindray Accutorr 7 Vital Signs Monitor Software Recall

    Mindray is recalling 107 Accutorr 7 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.

    Product
    Accutorr 7 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0238-2020·2019-11-06

    Mindray Rosebud Vital Signs Monitor Recalled for Unapproved Software Features

    Mindray is recalling 9 Rosebud Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.

    Product
    Rosebud Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0237-2020·2019-11-06

    Mindray Rosie4 Vital Signs Monitor Recalled for Software Clearance Issues

    Mindray is recalling 14 Rosie4 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.

    Product
    Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP). Te
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0235-2020·2019-11-06

    Mindray Accutorr 3 Vital Signs Monitor Recalled for Software Features

    Mindray is recalling 13 Accutorr 3 Vital Signs Monitors because the NIBP valve assembly board contains software features not included in the current marketing clearance.

    Product
    Accutorr 3 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for spot-check monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pres
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2019·2018-10-24

    Mindray BeneVision Distributed Monitoring System Recalled for ECG Display Anomalies

    Mindray is recalling five BeneVision Distributed Monitoring Systems due to a software issue that can cause ECG waveforms to display as a flat line when more than 64 telemetry transmitters are connected.

    Product
    Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1320-2018·2018-04-18

    Mindray Hematology Diluent M-30D Recalled for Elevated Platelet Background Counts

    Mindray is recalling specific lots of M-30D diluent used with BC-3200 and BC-3600 analyzers because they may cause the system to produce an elevated platelet background count.

    Product
    Hematology Diluent M-30D used with BC-3200 and BC-3600 Hematology Analyzer; Part Numbers: (1) 105-005405-00 (2 x 5.5L container), (2) 105-005406-00 (20L container) The M-30D Diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for u
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1321-2018·2018-04-18

    Mindray Hematology Diluent Recall for Elevated Platelet Background Counts

    Mindray is recalling specific lots of M-53D and M-30D hematology diluents because they may cause the analyzer to produce an elevated platelet background count.

    Product
    Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Devices)·Z-1242-2018·2018-04-04

    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.

    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, Isoflur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0847-2018·2018-03-14

    Mindray A7 Anesthesia Delivery System Recalled for Software Defect

    Mindray is recalling A7 Anesthesia Delivery Systems because a software issue may cause incorrect settings to be applied or the startup leak test to be skipped.

    Product
    A-Series A7 Anesthesia Delivery System; Model Number: 0632F-PA0000X (A7) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a patient s ventilation. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0846-2018·2018-03-14

    Mindray A-Series Anesthesia Delivery System Software Recall

    Mindray is recalling 2,875 A-Series anesthesia delivery systems due to a software issue that may apply incorrect settings or skip startup leak tests.

    Product
    A-Series A3/A5 Anesthesia Delivery System; Model Numbers: 0633F-01000-0X (A3) and 0631F-01000-0X (A5) Product Usage: The A-Series Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic, and to maintain a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0554-2018·2018-02-14

    Mindray TD60 Transmitter Battery Charger Recalled for Overcharging Risk

    Mindray is recalling 203 TD60 Transmitter battery chargers used with the BeneVision Central Station because a damaged circuit board can cause the battery to overcharge and the case to swell.

    Product
    TD60 Transmitter battery charger used with the BeneVision Central Station, Part number 115-030108-00
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-2634-2017·2017-07-05

    Mindray Recalls TI Transport Monitor Battery Packs Due to Overheating

    Mindray is recalling 2,718 TI Transport Monitor battery packs because two reports indicated the packs overheated.

    Product
    TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
    Category
    Medical Device
    Distribution
    Distributed nationwide