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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

709

Past Year

43

Class I (Serious)

3

Most Recent

Nov 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 1–20 of 709 recalls

Hardware configuration of the BeneVision Central Monitori... (Mindray DS USA, Inc. dba Mindray North America) – when the worstation of the benevision... (2025)

When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may experience audio playback failure or screen freezing.

FDANov 18, 2025Nationwide• Mindray DS USA, Inc. dba Mindray North America

Single Use Ligating Device (Olympus) – Loop Detachment Issue (2025)

Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.

FDAOct 30, 2025Nationwide• Olympus Corporation of the Americas

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

Potential for anesthesia leakage.

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

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

Potential for anesthesia leakage.

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

EZDilate Nephrostomy Catheter (Olympus) – Incorrect Balloon Size (2025)

Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.

FDAOct 17, 2025AK, CA, IA +3 more• Olympus Corporation of the Americas

EVIS EXERA III Duodenovideoscope (Olympus) – Reprocessing Update (2025)

Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.

FDAOct 14, 2025Nationwide• Olympus Corporation of the Americas

ShockPulse Lithotripsy Transducer (Olympus) – startup failure (2025)

The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.

FDAOct 8, 2025Nationwide• Olympus Corporation of the Americas

Single Use Electrosurgical Snare (Olympus) – sterility compromise (2025)

Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.

FDAOct 6, 2025Nationwide• Olympus Corporation of the Americas

Arctic Shores Frozen Cooked Shrimp (Great American) – insanitary conditions (2025)

Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.

Class IIModerate

FDASep 23, 2025AL, AZ, CA +31 more• Southwind Foods LLC dba Great American Seafood Imports Co.

Tovala Frozen Shrimp (Great American) – insanitary conditions (2025)

Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.

Class IIModerate

FDASep 23, 2025AL, AZ, CA +31 more• Southwind Foods LLC dba Great American Seafood Imports Co.

Great American Frozen Shrimp Skewer (Great American) – insanitary conditions (2025)

Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.

Class IIModerate

FDASep 23, 2025AL, AZ, CA +31 more• Southwind Foods LLC dba Great American Seafood Imports Co.

Arctic Shores Frozen Shrimp (Great American) – insanitary conditions (2025)

Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original recall.

Class IIModerate

FDASep 23, 2025AL, AZ, CA +31 more• Southwind Foods LLC dba Great American Seafood Imports Co.

FDR Visionary Suite (Fujifilm) – X-ray Support Defect (2025)

It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.

FDASep 15, 2025AK, CA, FL +5 more• FUJIFILM Healthcare Americas Corporation

Olympus EVIS EXERA II Bronchovideoscope (Olympus) – Usage Guidance Update (2025)

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

FDASep 11, 2025Nationwide• Olympus Corporation of the Americas

Olympus EVIS EXERA b Bronchovideoscope (Olympus) – Usage Guidance Update (2025)

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

FDASep 11, 2025Nationwide• Olympus Corporation of the Americas

Olympus Bronchovideoscope BF-H1100 (Olympus) – Usage Guidance Update (2025)

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

FDASep 11, 2025Nationwide• Olympus Corporation of the Americas

Olympus Bronchovideoscope BF 1T150 (Olympus) – Usage Guidance Update (2025)

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

FDASep 11, 2025Nationwide• Olympus Corporation of the Americas

Olympus EVIS EXERA III Bronchovideoscope (Olympus) – Usage Guidance Update (2025)

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

FDASep 11, 2025Nationwide• Olympus Corporation of the Americas

Olympus EVIS EXERA Bronchovideoscope (Olympus) – Usage Guidance Update (2025)

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

FDASep 11, 2025Nationwide• Olympus Corporation of the Americas

Olympus Bronchofiberscope BF 1T60 (Olympus) – Usage Guidance Update (2025)

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

FDASep 11, 2025Nationwide• Olympus Corporation of the Americas