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Mindray DS USA, Inc. dba Mindray North America

Mindray DS USA, Inc. dba Mindray North America Recalls

All product recalls associated with Mindray DS USA, Inc. dba Mindray North America.

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Recall Summary

Total Recalls

1000

Past Year

620

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 41–60 of 10937 recalls

Sevoflurane V90 Vaporizer (Mindray) – Anesthesia Leakage Risk (2025)

Potential for anesthesia leakage.

FDAOct 20, 2025Nationwide• Mindray DS USA, Inc. dba Mindray North America

HR-ACT Cartridges (Medtronic) – External Label Contamination (2025)

Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.

FDAOct 20, 2025Nationwide• Medtronic Perfusion Systems

Isoflurane V90 Vaporizer (Mindray) – Anesthesia Leakage Risk (2025)

Potential for anesthesia leakage.

FDAOct 20, 2025Nationwide

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• Mindray DS USA, Inc. dba Mindray North America

IntelePACS (Intelerad) – Software Communication Bug (2025)

Software application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.

FDAOct 17, 2025Nationwide• INTELERAD MEDICAL SYSTEMS INCORPORATED 800, Boul. de Maisonneuve Est 12th floor Montreal Canada

VANTAGE GALAN 3T (Canon Medical) – Electrode Distance Compliance (2025)

Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.

FDAOct 16, 2025NV, OH• Canon Medical System, USA, INC.

Ceiling Type X-Ray Tube Support (Shimadzu) – Mounting Shaft Risk (2025)

Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the rotating shaft.

FDAOct 16, 2025Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

Beckman Coulter Bicarbonate Reagent (Beckman) – Result Interference (2025)

Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.

FDAOct 14, 2025Nationwide• Beckman Coulter Ireland, Inc. Lismeehan O'Callaghan'S Mills Ireland

BD Luer Tip Caps (Becton Dickinson) – Biocompatibility Failure (2025)

BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.

FDAOct 14, 2025Nationwide• Becton Dickinson & Company

Fesoterodine Tablets (Alembic) – Impurity Levels (2025)

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

Class IIILow

FDAOct 10, 2025Nationwide• Alembic Pharmaceuticals Limited

bk3500 Ultrasound System (B-K Medical) – Battery Replacement Warning (2025)

GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.

FDAOct 9, 2025Nationwide• B-K Medical A/S Mileparken 34 Herlev Denmark

Myosa for Kids (Myofunctional) – Unauthorized Distribution (2025)

Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.

FDAOct 9, 2025Nationwide• Myofunctional Research Company USA

OC-Auto FOBT-CHEK Controls (Polymedco) – labeling error (2025)

A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be 2027-01-17.

FDAOct 6, 2025AL, AK, AZ +44 more• POLYMEDCO, INC. POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC

MC3 VitalFlow Console (Medtronic) – error code issue (2025)

As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recovering to full functionality. Importantly, the console continues to maintain set pump speed and function throughout.

FDAOct 3, 2025Nationwide• Medtronic Perfusion Systems

IV Administration Set (ICU Medical) – missing shutoff valve (2025)

IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.

FDAOct 2, 2025Nationwide• ICU Medical, Inc.

Magseed Pro 7cm Marker (Endomagnetics) – fiber contamination (2025)

Potential for contamination with cotton fibers.

FDAOct 1, 2025Nationwide• ENDOMAGNETICS LTD St. Johns Innovation Park Cowley Road Cambridge United Kingdom