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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 201–220 of 21319 recalls

Food Panel 3 Allergen (Siemens) – barcode scanning error (2025)

The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.

Low

FDAOct 6, 2025Nationwide• Siemens Healthcare Diagnostics, Inc.

Desipramine Tablets 10mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Desipramine Tablets 75mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

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Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Desipramine Tablets 25mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Desipramine Tablets 150mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Eterna SCS IPG (Abbott) – potential device issue (2025)

There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).

High

FDAOct 6, 2025Nationwide• Abbott Medical

NutraGlide Nasal Feeding Tube (Applied Medical) – occlusion risk (2025)

The nasal feeding tube may be occluded

High

FDAOct 6, 2025Nationwide• Applied Medical Technology Inc

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.

Low

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

Desipramine Tablets 100mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

Tavaborole Topical Solution 5% (Viona) – Discoloration (2025)

Discoloration

Class IIModerate

FDAOct 6, 2025Nationwide• VIONA PHARMACEUTICALS INC

Desipramine Tablets 50mg (Heritage) – Impurity Concerns (2025)

CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.

Class IIModerate

FDAOct 6, 2025Nationwide• Heritage Pharmaceuticals Inc

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.

Low

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.

Moderate

FDAOct 2, 2025Nationwide• ICU Medical, Inc.

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

Potential for contamination with cotton fibers.

Moderate

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

MAS Omni CARDIO Controls (Microgenics) – variability issue (2025)

The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.

Moderate

FDAOct 1, 2025Nationwide• Microgenics Corporation

ProxiDiagnost N90 (Philips) – carriage movement issue (2025)

Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potential manufacturing issues.

Moderate

FDAOct 1, 2025Nationwide• Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany

CombiDiagnost R90 (Philips) – carriage movement issue (2025)

Moderate

FDAOct 1, 2025Nationwide• Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany

MAGNETOM Cima.X Upgrade (Siemens) – ice blockage potential (2025)

There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary venting paths of the magnet helium containment venting system. In the event of a quench when both venting paths are blocked, helium gas may be unable to escape through the designed venting paths, leading to a pressure build-up within the helium containment system. This pressure build-up could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.

Moderate

FDAOct 1, 2025CA• Siemens Medical Solutions USA, Inc

DigitalDiagnost 4 (Philips) – carriage movement issue (2025)

Moderate

FDAOct 1, 2025Nationwide• Philips Medical Systems DMC GmbH Development And Manufacturing Ctr. Rontgenstr. 24 Hamburg Germany

Magseed Pro 12cm Marker (Endomagnetics) – fiber contamination (2025)

Potential for contamination with cotton fibers.

Moderate

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