Recall Register

Food, drugs, devices › Firms

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

FDA recalling firm · 8 enforcement events · 9 product records · 2010–2012 · NJ

Mindray DS USA, Inc. d.b.a. Mindray North America has 8 FDA enforcement events on this register (9 product records) between 2010 and 2012: 8 device; the busiest year was 2012 with 6.

13% of its events are Class I; the most common class is Class II (7). 0 events are listed as ongoing; the recalling firm's address is in NJ.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
28 Nov 2012BS-200 Chemistry Analyzer Designed for clinical laboratory use.DeviceClass II1Terminated
28 Nov 2012Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack. Part numbers: 300BF-PA00002, and 300BF-PA00003 (DPM Central Monitoring System) 115-006908-01, -03, -04 (DPM software upgrade kit). The DPM Central Monitoring System transfers information between DPM Central station and other networked…DeviceClass II1Terminated
24 Sep 2012Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series…DeviceClass II1Terminated
5 Sep 2012Mindray DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.DeviceClass II1Terminated
13 Aug 2012Mindray A3 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.DeviceClass I2Terminated
7 May 2012V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform…DeviceClass II1Terminated
12 May 2011DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables…DeviceClass II1Terminated
11 Aug 2010DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST…DeviceClass II1Terminated

By type and class

Device8
Class II7
Class I1

Class I: 13% of this firm's events; 18% of all events on the register.

Events by year

10
12
14
16
18
20
22
24
26
Enforcement events for Mindray DS USA, Inc. d.b.a. Mindray North America by year initiated.

Questions and answers

How many FDA recalls has Mindray DS USA, Inc. d.b.a. Mindray North America had?

8 enforcement events (9 product records) on this register, 2010–2012: 8 device.

Are any Mindray DS USA, Inc. d.b.a. Mindray North America recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Mindray DS USA, Inc. d.b.a. Mindray North America recalls?

7 Class II, 1 Class I. 13% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.