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Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. Recalls

All product recalls associated with Siemens Healthcare Diagnostics, Inc..

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

Most Recent

Jan 2026

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 2781–2800 of 21320 recalls

ADVIA Centaur EPO Assay (Siemens) – Result Bias (2024)

Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.

Moderate

FDAJan 24, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Stay-Safe Luer Lock Catheter Extension (Fresenius) – Leachable Concerns (2024)

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

Moderate

FDAJan 23, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Stay-Safe Luer Lock Adapter (Fresenius) – Leachable Concerns (2024)

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

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Moderate

FDAJan 23, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Stay-Safe Luer Catheter Extension (Fresenius) – Leachable Concerns (2024)

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

Moderate

FDAJan 23, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Stay-Safe Safe Lock Catheter Extension (Fresenius) – Leachable Concerns (2024)

The peroxide cross-linked tubing has leachables identified as NDL PCBAs.

Moderate

FDAJan 23, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

VITROS 5600 Integrated System (Ortho-Clinical) – Sample Aspiration Risk (2024)

Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems which may lead to erroneous test results.

Moderate

FDAJan 22, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Duet External Drainage System (Medtronic) – Catheter Disconnection Risk (2024)

Potential for catheter disconnection from the patient line stopcock connectors.

High

FDAJan 22, 2024Nationwide• Medtronic Neurosurgery

Epidural Tray (B. Braun) – Connector Compatibility Issue (2024)

Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter Straws with Neuraxial connectors preventing interface with the other components of the kit.

High

FDAJan 22, 2024Nationwide• B. Braun Medical, Inc.

VITROS 3600 Immunodiagnostic System (Ortho-Clinical) – Sample Aspiration Risk (2024)

Moderate

FDAJan 22, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

VITROS XT7600 Integrated System (Ortho-Clinical) – Sample Aspiration Risk (2024)

Moderate

FDAJan 22, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Vasopressin Injection (IntegraDose) – Sub-potent Drug (2024)

Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.

Class IIModerate

FDAJan 22, 2024MN• IntegraDose Compounding Services LLC

IC Bus EVSB (IC Bus) – High Voltage Cable Problem (2024)

Navistar, Inc. (Navistar) is recalling certain 2024 IC EV school buses. The high voltage positive cables that connect the battery packs to the manual service disconnects (MSD) may have been mislabeled.

High

NHTSAJan 18, 2024Nationwide• IC BUS