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Siemens Medical Solutions USA, Inc

Siemens Medical Solutions USA, Inc Recalls

All product recalls associated with Siemens Medical Solutions USA, 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 781–800 of 21319 recalls

UROSKOP Omnia Max (Siemens Medical) – Frequency Inverter Fire Risk (2025)

Fire/Burn Risk

A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

High

FDAJun 4, 2025Nationwide• Siemens Medical Solutions USA, Inc

SwabCap Disinfecting Cap (ICU Medical) – Seal Integrity Issue (2025)

Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.

High

FDAJun 3, 2025Nationwide• ICU Medical, Inc.

BD FACS Setup Beads (Becton Dickinson) – Spectral Overlap Error (2025)

Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.

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Moderate

FDAJun 3, 2025AZ, AR, CA +34 more• Becton, Dickinson and Company, BD Bio Sciences

Hamilton C6 (Hamilton Medical) – Circuit Board Mechanical Defect (2025)

A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.

Very High

FDAJun 3, 2025Nationwide• Hamilton Medical AG Parc Industrial Vial 10 Domat/Ems Switzerland

BD FACS Setup Beads (Becton Dickinson) – Spectral Overlap Error (2025)

Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.

Moderate

FDAJun 3, 2025AZ, AR, CA +34 more• Becton, Dickinson and Company, BD Bio Sciences

Sulfamethoxazole Trimethoprim Tablets (Amneal) – Microbial Contamination (2025)

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

Class IHigh

FDAJun 2, 2025Nationwide• Amneal Pharmaceuticals, LLC

Servo-u MR Ventilator (Maquet) – Patient Circuit Test Error (2025)

Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.

Moderate

FDAMay 30, 2025Nationwide• Maquet Critical Care AB Rontgenvagen

Servo-u Ventilator (Maquet) – Patient Circuit Test Error (2025)

Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.

Moderate

FDAMay 30, 2025Nationwide• Maquet Critical Care AB Rontgenvagen

Inseego USB8 4G Dongle Kit (Remote Diagnostic) – Outdated Software (2025)

Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.

High

FDAMay 30, 2025Nationwide• Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom

Icosapent Ethyl Capsules (Zydus) – Burnt Capsules (2025)

Fire/Burn Risk

Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsules. This was determined to be a result of oxidation by leakage of capsule contents.

Class IIModerate

FDAMay 30, 2025IL, MS, PA• Zydus Pharmaceuticals (USA) Inc

Testo-200 Testosterone Injection (Advanced Pharma) – Unapproved Product (2025)

Marketed Without an Approved NDA/ANDA

Class IIModerate

FDAMay 30, 2025NJ, NY• Advanced Pharmaceutical Technology, Inc.

Servo-n Ventilator (Maquet) – Patient Circuit Test Error (2025)

Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.

Moderate

FDAMay 30, 2025Nationwide• Maquet Critical Care AB Rontgenvagen

Kitchen Faucet (BASDEHEN) – Lead Exposure (2025)

This recall involves BASDEHEN kitchen faucets, model number CFDTTH-000-YGH. The faucets are matte black single-handle kitchen faucets with 360° swivel, spring spout design, detachable spray, optional mounting plate and single-hole installation. Consumers can identify whether they have a recalled faucet by searching their Amazon purchase history for "Basdehen" and "kitchen faucet."

Very High

CPSCMay 29, 2025Nationwide• Ruianshichenfengwujinzhizaoyouxiangongsi, of China, doing business as Amazon seller Chenfeng Store

Kitchen Faucet (KICIMPRO) – Lead Exposure (2025)

This recall involves KICIMPRO kitchen faucets, model number KM800-01-06BN. The faucets are brushed nickel, single-handle kitchen faucets with a pull-down detachable spray and single-hole installation. Consumers can identify whether they have a recalled faucet by searching their Amazon purchase history for "Kicimpro" and "kitchen faucet" and looking for a description including pull-down sprayer, brushed nickel, high-arc, single-handle sink faucet with water lines, commercial modern RV stainless steel, grifos de cocina.

Very High

CPSCMay 29, 2025Nationwide• Kaipingshikemuyulinweiyushiyeyouxiangongsi, of China, doing business as Amazon seller Kicimpro

Intera 1.5T Achieva IT Nova (Philips) – Heat Source Risk (2025)

Fire/Burn Risk

identified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a potential to produce smoke and/or fire. If smoke or a fire occurs, the risk to patients or operators may include inhalation of smoke, burns, and/or asphyxia which may lead to injury or even death. This issue could also lead to property damage.

Very High

FDAMay 29, 2025Nationwide• Philips North America

Stay Informed

Siemens Medical Solutions USA, Inc Recalls

Recall Summary

UROSKOP Omnia Max (Siemens Medical) – Frequency Inverter Fire Risk (2025)

SwabCap Disinfecting Cap (ICU Medical) – Seal Integrity Issue (2025)

BD FACS Setup Beads (Becton Dickinson) – Spectral Overlap Error (2025)

Hamilton C6 (Hamilton Medical) – Circuit Board Mechanical Defect (2025)

BD FACS Setup Beads (Becton Dickinson) – Spectral Overlap Error (2025)

Sulfamethoxazole Trimethoprim Tablets (Amneal) – Microbial Contamination (2025)

Servo-u MR Ventilator (Maquet) – Patient Circuit Test Error (2025)

Servo-u Ventilator (Maquet) – Patient Circuit Test Error (2025)

Inseego USB8 4G Dongle Kit (Remote Diagnostic) – Outdated Software (2025)

Icosapent Ethyl Capsules (Zydus) – Burnt Capsules (2025)

Testo-200 Testosterone Injection (Advanced Pharma) – Unapproved Product (2025)

Servo-n Ventilator (Maquet) – Patient Circuit Test Error (2025)

Kitchen Faucet (BASDEHEN) – Lead Exposure (2025)

Kitchen Faucet (KICIMPRO) – Lead Exposure (2025)

Intera 1.5T Achieva IT Nova (Philips) – Heat Source Risk (2025)

Intera 1.5T Achieva Nova-Dual (Philips) – Heat Source Risk (2025)

Intera 1.5T Omni/Stellar (Philips) – Heat Source Risk (2025)

Intera 1.5T Explorer/Nova Dual (Philips) – Heat Source Risk (2025)

Intera 1.5T Master/Nova (Philips) – Heat Source Risk (2025)

SmartPath to dStream for 1.5T (Philips) – Heat Source Risk (2025)