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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)

143

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 3021–3040 of 37665 recalls

Atellica CH Microalbumin (Siemens) - Performance Claim Issue (2024)

Atellica CH Microalbumin_2 (ALB_2) and the ADVIA Chemistry Microalbumin_2 (ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect claim as stated in the Instructions for Use (IFU) on the Atellica CH, Atellica CI Analyzers, ADVIA 1800 Chemistry Systems, ADVIA 2400 Chemistry Systems, and ADVIA Chemistry XPT Systems, may result in erroneously depressed microalbumin patient results.

Moderate

FDAAug 15, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Chocolate Fudge (Authentik Fudge) – Mold Contamination (2024)

Product may be contaminated with mold.

Class IIModerate

FDAAug 14, 2024AZ, CA, CO +37 more• AUTHENTIK FUDGE

Tegaderm CHG (3M) - Foreign Substance Contamination (2024)

Contamination with foreign substance matter

1...150 151152153 154...1884

Page 152 of 1884Next

Moderate

FDAAug 14, 2024Nationwide• 3M Company Health Care Business 3m Center

Spacelabs Ultraview DM4 (Zoe Medical) - Battery Risk (2024)

This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.

Moderate

FDAAug 13, 2024Nationwide• Zoe Medical Incorporated

Spacelabs Ultraview DM3 (Zoe Medical) - Battery Risk (2024)

This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.

Moderate

FDAAug 13, 2024Nationwide• Zoe Medical Incorporated

Soltive Pro Laser (Olympus) - Translation Error (2024)

The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.

High

FDAAug 13, 2024Nationwide• Olympus Corporation of the Americas

Soltive Premium Laser (Olympus) - Translation Error (2024)

Moderate

FDAAug 13, 2024Nationwide• Olympus Corporation of the Americas

Rotation Medical Tendon Staples (Smith & Nephew) - Packaging Seal Defect (2024)

Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility

Moderate

FDAAug 12, 2024Nationwide• Smith & Nephew Inc.

Seer Home EEG System (Seer Medical) - EMC Assessment Gap (2024)

During CAPA investigations of sight production inconsistencies, it was highlighted that previous Electromagnetic Compatibility (EMC) assessments related to RF radiated emissions may not be reasonably equivalent to the current product due to design changes in the system. A new CAPA was opened to investigate the radiated emissions compliance issues. - Seer Home Systems distributed and retained in the field were not compliant with Electromagnetic Compatibility (EMC) testing according to IEC 60601-1-2 - Seer Home Systems, including accessories, were manufactured and distributed without application of proper design change and manufacturing controls - Seer Home Systems were distributed with labeling deficiencies

High

FDAAug 12, 2024Nationwide• SEER MEDICAL PTY LTD 278-284 Queensberry St Melbourne Australia

Prelude Sheath Introducer (Merit Medical) - Incorrect Size Labeling (2024)

7F sheath introducers labeled as 7.5F

Moderate

FDAAug 12, 2024Nationwide• Merit Medical Systems, Inc.

Triple E Unity (Triple E) - Propane Line Issue (2024)

Fire/Burn Risk

Triple E Recreational Vehicles (Triple E) is recalling certain 2024 Triple E Unity U24RL, U24TB, U24FX, and U24MBL motorhomes. The RVMP generator propane hose may be incorrectly routed too close to the generator exhaust, which can result in a fuel leak.

High

NHTSAAug 12, 2024Nationwide• TRIPLE E

BD FACSDuet Preparation System (BD) - Sample Dispensing Error (2024)

Sample preparation system with software may cause: 1) Multidispense feature enabled with 2-tube assay: Specimen volume dispensed into tube1 at least 3% higher than volume in tube2, or 2) Absolute counts calculated using Trucount Tubes: increased volume in tube1 may result in 20% higher absolute counts in tube 1 than tube 2; could result in additional blood collection, delayed results/patient therapy.

Moderate

FDAAug 12, 2024AK, CA, ID +10 more• Becton, Dickinson and Company, BD Bio Sciences

Custom Procedure Kit (Merit Medical) - Incorrect Size Labeling (2024)

7F sheath introducers labeled as 7.5F

Moderate

FDAAug 12, 2024Nationwide• Merit Medical Systems, Inc.

Timolol Maleate Eye Solution (FDC Limited) – Defective Container (2024)

Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.

Class IIModerate

FDAAug 12, 2024Nationwide• FDC Limited

Kettle Glazed Walnuts (Flagstone Foods) – Undeclared Nuts (2024)

Undeclared Nuts

undeclared peanuts, almonds and pecans

Class IIModerate

FDAAug 12, 2024AL, FL, GA +1 more• Flagstone Foods, LLC

GE Giraffe Warmer (GE HealthCare) - Electrical Safety Gap (2024)

GE HealthCare has become aware that complete electrical safety testing was not conducted during manufacturing of certain Giraffe and Panda iRes Warmers. There are multiple electrical safety protections included in the product design. However, because the electrical safety testing in manufacturing was incomplete for these devices, there is the potential for leakage current to exceed IEC 60601 limits.

High

FDAAug 9, 2024Nationwide• Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India

GE Panda iRES Warmer (GE HealthCare) - Electrical Safety Gap (2024)

High

FDAAug 9, 2024Nationwide• Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India

ViewPoint Imaging System (GE Healthcare) - Cybersecurity Vulnerability (2024)

The National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth Connect, prior to version 4.4.1, has a potential vulnerability allowing the deserialization of untrusted data (CVE-2023-43208). Mirth products may have been installed and configured with your ViewPoint / ViewPoint 6 system by GE HealthCare. This vulnerability could allow a malicious actor to access the system and potentially manipulate patient data.

High

FDAAug 8, 2024Nationwide• GE Healthcare GmbH Oskar-Schlemmer-Str. 11 Munich Germany

Biolox Option Taper Sleeve (Zimmer) - Mislabeling Concern (2024)

Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6

Moderate

FDAAug 8, 2024Nationwide• Zimmer GmbH Sulzerallee 8 Winterthur Switzerland

Philips Allura Xper System (Philips) - Bolt Placement Error (2024)

A half-threaded bolt was included in the LTE kits instead of the correct full-threaded bolt.

Moderate

FDAAug 8, 2024Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands