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
/
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku Recalls

All product recalls associated with SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku.

Get alerts for this brand

Recall Summary

Total Recalls

1000

Past Year

898

Class I (Serious)

125

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 1201–1220 of 17592 recalls

Trinias Unity (Shimadzu) – Movement Interference Risk (2024)

If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move, which the operator can stop by pressing the stop button.

Moderate

FDASep 6, 2024Nationwide• SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION Nishinokyo Kuwabara Cho Nakagyo-Ku

EnChroma Safety Glasses (Enchroma) – Impact Protection Failure (2024)

Safety glasses with Rx indoor universal lenses fail to meet high impact safety specifications, which may not provide adequate protection against impact, posing a risk of eye injury.

High

FDASep 6, 2024Nationwide• Enchroma Inc

Access Thyroglobulin Antibody (Beckman) – Result Accuracy Issue (2024)

IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.

1...59 606162 63...880

Page 61 of 880Next

Low

FDASep 5, 2024Nationwide• Beckman Coulter, Inc.

Kandy Cantaloupe (Martori Farms) – Salmonella Contamination (2024)

Salmonella

Possible contamination with Salmonella spp.

Class IHigh

FDASep 5, 2024MI, MO, OH +2 more• Eagle Produce LLC, dba Martori Farms

BK Medical Ultrasound (B-K Medical) – Power Connection Risk (2024)

The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.

High

FDASep 4, 2024Nationwide• B-K Medical A/S Mileparken 34 Herlev Denmark

Leica Biosystems Cryostat (Leica) – Flammable Spray Risk (2024)

As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.

High

FDASep 4, 2024Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

EVSRF Catheter (Bard) – Wiring Error Risk (2024)

The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire configuration would lead to power being applied through the proximal 3/4th of the heating coil, bypassing the thermocouple, which will then cause the generator to overdrive the catheter in an attempt to reach desired temperature set point. The wire attachment error causes the device to reach temperatures exceeding the levels intended for therapeutic efficacy, while the console is falsely indicating that temperature has not yet been reached, thus increasing the risk of harm due to excessive temperature.

High

FDASep 4, 2024Nationwide• Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438

Olympus Electrosurgical Generator (Olympus) – System Error Risk (2024)

There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).

Moderate

FDASep 4, 2024Nationwide• Olympus Corporation of the Americas

Epikut S Plus CM Implant (SIN) – Diameter Labeling Error (2024)

Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.

High

FDASep 1, 2024CA, CO, FL +7 more• SIN SISTEMA DE IMPLANTE NACIONAL S.A Jardim Analia Franco Rua Soldador Ocimar Guimaraes da Silva

Predict+ Tool (Blue Ortho) – Pre-Market Clearance Problem (2024)

Predict+ is being recalled for lack of pre-market clearance/approval.

Low

FDAAug 30, 2024Nationwide• Blue Ortho 22 Chemin Du Vieux Chene Meylan France

Neo-Tee Resuscitator (Mercury) – Manufacturing Step Issue (2024)

Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

High

FDAAug 30, 2024FL, IN, MI +2 more• Mercury Enterprises, Inc. dba Mercury Medical

Monarch Inflation Device (Merit) – Sterile Barrier Breach (2024)

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

High

FDAAug 30, 2024Nationwide• Merit Medical Systems, Inc.

Melrose Injector (Merit) – Sterile Barrier Breach (2024)

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

High

FDAAug 30, 2024Nationwide• Merit Medical Systems, Inc.

Monarch Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.

Moderate

FDAAug 30, 2024Nationwide• Merit Medical Systems, Inc.

Hemo-7 Hemospray (Wilson-Cook) – Raw Material Nonconformance (2024)

Specific lots of product have been manufactured with nonconforming raw materials.

Moderate

FDAAug 29, 2024Nationwide• Wilson-Cook Medical Inc.

Kara Boondhi (Grace Imports) - Undeclared Wheat (2024)

Undeclared Allergen

Undeclared wheat. The firm was notified by their supplier that they failed to include the allergen "wheat" on the label.

Class IIModerate

FDAAug 29, 2024GA, IN• Grace Imports, Inc

Spicy Murukku Ingredients (Grace Imports) - Undeclared Wheat (2024)

Undeclared Allergen

Undeclared wheat. The firm was notified by their supplier that they failed to include the allergen "wheat" on the label.

Class IIModerate

FDAAug 29, 2024GA, IN• Grace Imports, Inc

Kerala Mixture (Grace Imports) - Undeclared Wheat (2024)

Undeclared Allergen

Undeclared wheat. The firm was notified by their supplier that they failed to include the allergen "wheat" on the label.

Class IIModerate

FDAAug 29, 2024GA, IN• Grace Imports, Inc

Good Vibrations Ultrasonic Cleaner (Microcare) – Bacterial Contamination (2024)

Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic detergent, which caused product bloating/leaking, and if used during medical/dental procedures could result in urinary tract, respiratory, bloodstream infections; workers handling contaminated product/instruments also at risk

High

FDAAug 29, 2024Nationwide• Microcare Medical

Access TSH Assay (Beckman Coulter) – Erroneously Low Results (2024)

Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.

Moderate

FDAAug 28, 2024Nationwide• Beckman Coulter, Inc.