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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

49

Class I (Serious)

29

Most Recent

Dec 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 81–100 of 1121 recalls

ACUSON Redwood Ultrasound (Siemens) – Cardiac Measurement Error (2024)

On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.

FDAFeb 23, 2024Nationwide• Siemens Medical Solutions USA, Inc.

Lidocaine HCL Solution (Denver Solutions) – glass delamination (2024)

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Class IIModerate

FDAFeb 20, 2024Nationwide• Denver Solutions, LLC DBA Leiters Health

Moxifloxacin Single-Dose Vial (Denver Solutions) – glass delamination (2024)

1...3 456 7...57

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Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Class IIModerate

FDAFeb 20, 2024Nationwide• Denver Solutions, LLC DBA Leiters Health

Moxifloxacin Balanced Salt Solution (Denver Solutions) – glass delamination (2024)

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Class IIModerate

FDAFeb 20, 2024Nationwide• Denver Solutions, LLC DBA Leiters Health

PHENYLephrine HCl Lower Dose IV Solution (Denver Solutions) – Double Dose Risk (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

FentaNYL Citrate IV Solution (Denver Solutions) – Double Dose Risk (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

FentaNYL Citrate Large IV Solution (Denver Solutions) – Double Dose Risk (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Vancomycin IV Bag (Denver Solutions) – Dosage Malfunction (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

PHENYLephrine HCl IV Solution (Denver Solutions) – Double Dose Risk (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

VANCOmycin HCl IV Solution (Denver Solutions) – Double Dose Risk (2023)

Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.

FDADec 28, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

GE Electric Cooktop - Burn Risk (2023)

This recall involves GE-branded JP3030 knob-controlled electric radiant cooktops manufactured from July 2022 through September 2022 with serial numbers beginning with prefixes LT, MT, RT or ST. The recalled cooktops have black or white glass cooktop surfaces and have four radiant burners with four corresponding "Hot Cooktop" lights and four burner control knobs located on the right side of the cooking surface. The following model numbers, UPC codes, and serial number prefixes are included in this recall: Model Number UPC Code Serial Number or Serial Number Prefix JP3030DJ4BB 084691809609 LT081195Q - LT081286Q MT- RT- ST- JP3030SJ4SS 084691809074 LT015466Q - LT015467Q LT048419Q - LT048420Q LT073851Q LT129159Q - LT129183Q MT- RT- ST- JP3030TJ4WW 084691809081 LT148064Q - LT148068Q LT118335Q MT- RT- ST- The model number, UPC code, and serial number of the cooktops are printed on the permanent on-product label located on the bottom of the unit, close to the front left burner location.

CPSCNov 30, 2023Nationwide• Haier US Appliance Solutions Inc., d/b/a GE Appliances, of Louisville, Kentucky

Sensis Vibe Hemo (Siemens) – Documentation Crash (2023)

The possibility of the Sensis documentation functionality application to crash.

FDANov 29, 2023CA, CT, FL• Siemens Medical Solutions USA, Inc

Liberty Medical Solutions, LLC: Multi-Mode Stimulator, Transcutaneous Electrical Nerve St...

The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.

FDANov 3, 2023Nationwide• Liberty Medical Solutions, LLC

Siemens Medical Solutions USA, Inc: ARTIS icono (ceiling configuration), Fluoroscopic x-ray s...

Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.

FDAOct 17, 2023Nationwide• Siemens Medical Solutions USA, Inc

JayRobb Egg White Protein Powder (Select Custom) – Foreign Plastic (2023)

foreign material - plastic

Class IIModerate

FDAOct 13, 2023Nationwide• Select Custom Solutions, LLC

Siemens Medical Solutions USA, Inc: Mobilett Mira wireless (VA20) mobile x-ray system(s)

Due to the incorrect mounting of the buzzer component, there is no acoustic signal during x ray activation. Otherwise, the system is fully functional, and x ray is applied correctly. By means of the additional visual indicator (exposure LED light) the operator can monitor the x ray release. Also, after a successful x ray exposure, the clinical image is displayed on the monitor.

FDAOct 5, 2023Nationwide• Siemens Medical Solutions USA, Inc

Vancomycin HCI IV Bag (Denver Solutions) – Labeling Issue (2023)

Labeling: Not Elsewhere Classified

FDAOct 4, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Vancomycin HCI IV Bag (Denver Solutions) – Labeling Issue (2023)

Labeling: Not Elsewhere Classified

FDAOct 4, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Oxytocin IV Bag (Denver Solutions) – Labeling Issue (2023)

Labeling: Not Elsewhere Classified

FDAOct 4, 2023Nationwide• Denver Solutions, LLC DBA Leiters Health

Siemens Medical Solutions USA, Inc: Updated 12/4/23 (1) Cios Flow (VA30) mobile fluoros...

Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure

FDASep 12, 2023Nationwide• Siemens Medical Solutions USA, Inc