Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Fujifilm Medical Systems U.S.A., Inc.

Fujifilm Medical Systems U.S.A., Inc. Recalls

All product recalls associated with Fujifilm Medical Systems U.S.A., Inc..

Get alerts for this brand

Recall Summary

Total Recalls

1000

Past Year

579

Class I (Serious)

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 3641–3660 of 10937 recalls

Synapse PACS Software (Fujifilm) - CT study value error (2020)

FUJIFILM has become aware of the possibility that certain CT studies may report a much higher 3D Sphere MAX value than expected. This issue is specific to 3D Sphere - other density tools are not affected.

Low

FDASep 11, 2020Nationwide• Fujifilm Medical Systems U.S.A., Inc.

Synapse PACS Software (Fujifilm) - Patient information display error (2020)

There is a potential for the wrong patient information may be displayed in the viewer or PowerJacket. Additionally, the incorrect max standard uptake values (SUV) for PET ad CT studies may be returned for Siemens Modality.

Moderate

FDASep 11, 2020Nationwide• Fujifilm Medical Systems U.S.A., Inc.

Genesis Hand Sanitizer Gel (Genesis Partnership) – Manufacturing Deviation (2020)

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.

1...181 182183184 185...547

Page 183 of 547Next

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Genesis Hand Sanitizer Gel (Genesis Partnership) – Manufacturing Deviation (2020)

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Killz Germz Hand Sanitizer (Genesis Partnership) – Sub-Potent Ethanol (2020)

Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Killz Germz Hand Sanitizer (Genesis Partnership) – Sub-Potent Alcohol (2020)

Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol levels as low as 62% while labelled claim is 70%.

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Panagel Hand Sanitizer (Genesis Partnership) – Manufacturing Deviation (2020)

CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facility as another hand sanitizer product with sub-potent ethanol levels.

Class IIModerate

FDASep 11, 2020Nationwide• Genesis Partnership Company SA

Wintergreen Essential Oil (Organic Aromas) – Packaging Risk (2020)

This recall involves Organic Aromas Wintergreen Essential Oil in amber glass bottles with white or black caps. The product is packaged in 10mL, 30mL, and 50mL sizes. The firm name "Organic Aromas," the firm's logo, and "Wintergreen Pure Essential Oil," along with the volume amounts are printed on the white label. A 2mL size that was sold as part of a set of sample sizes of assorted oils and called the "Discovery Collection," is also subject to this recall. "WNTRGRN" is printed on a green label on the cap with the firm's logo on the side of the package.

High

CPSCSep 10, 2020Nationwide• Organic Aromas, of Taiwan

Citalopram Oral Solution (PAI Holdings) – Impurity Specification Failure (2020)

Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint

Class IIILow

FDASep 9, 2020Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

AC/DC Power Supply (ESAOTE) - Connector heating risk (2020)

The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result in the connector heating up, generating smoke and melting. This condition is caused by the mechanical stress of the connection between the AC/DC power adapter and the mains cable over the time of use.

FDASep 8, 2020Nationwide• ESAOTE S.P.A Via Enrico Melen

Neoprobe GDS Control Unit (Devicor) - Software version issue (2020)

It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.

FDASep 7, 2020Nationwide• Devicor Medical Products Inc

Flat Parsley (Tim Campbell Farm) - Listeria Contamination (2020)

Listeria

product tested positive for Listeria monocytogenes

Class IHigh

FDASep 2, 2020MI• Tim Campbell Farm LLC

Syringe with Spinning Spiros (ICU Medical) – Luer Leak Risk (2020)

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

FDAAug 31, 2020Nationwide• ICU Medical, Inc.

Stay Informed

Fujifilm Medical Systems U.S.A., Inc. Recalls

Recall Summary

Synapse PACS Software (Fujifilm) - CT study value error (2020)

Synapse PACS Software (Fujifilm) - Patient information display error (2020)

Genesis Hand Sanitizer Gel (Genesis Partnership) – Manufacturing Deviation (2020)

Genesis Hand Sanitizer Gel (Genesis Partnership) – Manufacturing Deviation (2020)

Killz Germz Hand Sanitizer (Genesis Partnership) – Sub-Potent Ethanol (2020)

Killz Germz Hand Sanitizer (Genesis Partnership) – Sub-Potent Alcohol (2020)

Panagel Hand Sanitizer (Genesis Partnership) – Manufacturing Deviation (2020)

Wintergreen Essential Oil (Organic Aromas) – Packaging Risk (2020)

Citalopram Oral Solution (PAI Holdings) – Impurity Specification Failure (2020)

AC/DC Power Supply (ESAOTE) - Connector heating risk (2020)

Neoprobe GDS Control Unit (Devicor) - Software version issue (2020)

Flat Parsley (Tim Campbell Farm) - Listeria Contamination (2020)

Syringe with Spinning Spiros (ICU Medical) – Luer Leak Risk (2020)

Admin Set (ICU Medical) – Luer Connection Leak (2020)

Spinning Spiros Luer (ICU Medical) – Leak Potential (2020)

Admin Set (ICU Medical) – Luer Connection Leak (2020)

Bag Spike (ICU Medical) – Luer Connection Leak (2020)

Admin Set (ICU Medical) – Luer Connection Leak (2020)

Admin Set (ICU Medical) – Luer Connection Leak (2020)

Spiros Closed Male Luer (ICU Medical) – Leak Potential (2020)