Recall Record

Mahwah, NJ, United States

Mindray DS USA, Inc. dba Mindray North America recalls

14 recalls recorded since 2018, most recently on 18 November 2025. 5 are listed as ongoing. Status and classification are as published by the FDA.

Recalls14
Ongoing (FDA)5
Terminated or completed9
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
18 November 2025
Reason
When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Initiated
Voluntary: Firm initiated
Recall number
Z-0920-2026

Ongoing Class II Medical devices

Recall started
20 October 2025
Reason
Potential for anesthesia leakage.
Distribution
Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia and the country of Canada.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0720-2026, Z-0721-2026

Ongoing Class II Medical devices

Recall started
15 August 2025
Reason
Potential for activation of an abnormal alarm pause.
Distribution
Worldwide - Nationwide distribution and the country of Canada.
Initiated
Voluntary: Firm initiated
Recall number
Z-2622-2025

Ongoing Class II Medical devices

Recall started
22 July 2024
Reason
V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a component within the vaporizer causing an incomplete seal in some cases. Should this issue occur, the A9 Anesthesia System will generate alarms associated with abnormal vaporizer output. If the anesthetic concentration is too high, the patient can inhale too much anesthetic agent; the patient may suffer from symptoms such as vertigo and drowsiness after the operation. In severe cases, the patient may suffer from neurological sequelae such as hypomnesia and inattention
Distribution
US Distribution to states of: California, Georgia, Kentucky, Mississippi, New Jersey, Puerto Rico, Texas, and West Virginia; and International (Foreign) to: Canada
Initiated
Voluntary: Firm initiated
Recall numbers
Z-2950-2024, Z-2952-2024, Z-2951-2024, Z-2949-2024

Terminated Class III Medical devices

Recall started
27 May 2021
Terminated
11 August 2022
Reason
Telepack may not power on when using the 3AA battery cradle.
Distribution
Distributed US nationwide and Canada.
Initiated
Voluntary: Firm initiated
Recall number
Z-2108-2021

Ongoing Class II Medical devices

Recall started
22 February 2021
Reason
BeneVision DMS may intermittently freeze and require a manual reboot after which normal operation resumes. If a freeze occur, patients monitored on a telemetry transmitter will no longer communicate data to the BeneVision DMS
Distribution
Nationwide Canada
Initiated
Voluntary: Firm initiated
Recall number
Z-1254-2021

Terminated Class II Medical devices

Recall started
13 January 2020
Terminated
21 August 2020
Reason
The DP-30 displays an incorrect needle-guide bracket when used with the 65EC10EA model transducer.
Distribution
US Nationwide distribution in the states of CA, GA, IL, MD, NY, SC, and WA.
Initiated
Voluntary: Firm initiated
Recall number
Z-1330-2020

Terminated Class II Medical devices

Recall started
9 December 2019
Terminated
17 September 2020
Reason
The gas spring on the front and rear protective cover may fail. There is a low risk of injury to the user resulting from failure of the gas spring. Injury may include impact to the arms, hands or fingers.
Distribution
The products were distributed to the following US states: MI and TX.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0921-2020, Z-0920-2020

Terminated Class II Medical devices

Recall started
1 October 2019
Terminated
6 August 2021
Reason
NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature 2. NIBP hose blockage identification function
Distribution
US Nationwide distributions.
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0235-2020, Z-0238-2020, Z-0237-2020, Z-0236-2020

Terminated Class II Medical devices

Recall started
30 August 2018
Terminated
20 December 2018
Reason
The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG waveforms to appear as a flat line at the centralized viewing station and will manifest if more than 64 TD60 transmitters have been connected to a given central station server. Each central station supports only 32 transmitters at a time. For the issue to manifest, the BeneVision DMS needs to be configured to use flexible device assignment, have more than 64 TD60 transmitters, and the workflow must allow 64 TD60s to move around between multiple central stations in the same care area.
Distribution
Distributed to accounts in CA, CO, FL, MA, NY, PA, PR, TX, and WV.
Initiated
Voluntary: Firm initiated
Recall number
Z-0170-2019

Terminated Class II Medical devices

Recall started
24 January 2018
Terminated
19 April 2019
Reason
Certain lots of M-30D diluent used with BC-3200 and BC-3600 Hematology Analyzers and M-53D diluent used with BC-5390 Hematology Analyzers may cause the system to produce an elevated platelet background count.
Distribution
US Distribution including Puerto Rico and to the states of : CA, MI, NC, TX, and WA. .
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1320-2018, Z-1321-2018

Terminated Class III Medical devices

Recall started
1 December 2017
Terminated
29 August 2018
Reason
The firm made multiple changes to the product requiring the submission of a new 510(k) premarket notification.
Distribution
Worldwide Distribution - U.S. Nationwide in the states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY, including Puerto Rico and distributed to 30 foreign consignees.
Initiated
Voluntary: Firm initiated
Recall number
Z-1242-2018

Terminated Class II Medical devices

Recall started
14 July 2017
Terminated
17 April 2019
Reason
A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.
Distribution
Worldwide Distribution - US Nationwide
Initiated
Voluntary: Firm initiated
Recall numbers
Z-0847-2018, Z-0846-2018

Terminated Class II Medical devices

Recall started
14 July 2017
Terminated
17 December 2018
Reason
A damaged circuit board in the battery charger can cause the battery to overcharge and the battery case to swell and separate.
Distribution
Distributed in 26 states: AL, CA, CO, FL, GA, IA, IN, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, PA, SD, TX, UT, WA, and WY; and Puerto Rico.
Initiated
Voluntary: Firm initiated
Recall number
Z-0554-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.