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Hitachi Healthcare Americas Corporation

Hitachi Healthcare Americas Corporation Recalls

All product recalls associated with Hitachi Healthcare Americas Corporation.

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Recall Summary

Total Recalls

1000

Past Year

891

Class I (Serious)

124

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 4941–4960 of 17593 recalls

L43K Intraoperative Probe (Hitachi) – Screw Cover Failure (2021)

The screw cover at the tip of the probe may fall off after a cleaning and sterilization process. Users advised to conduct a preventive inspection of the probe before and after sterilization/disinfection/cleaning and before and after an interoperative procedure.

Moderate

FDAJun 30, 2021Nationwide• Hitachi Healthcare Americas Corporation

L9 Engine (Cummins) – Injection Software Issue (2021)

Cummins, Inc. (Cummins) is recalling certain L9 Diesel Engines, with part number D563027BX03. The engine calibration software's management of the injection of Diesel Exhaust Fluid can allow excessive ammonia into the tailpipe exhaust.

Moderate

NHTSAJun 29, 2021Nationwide• CUMMINS

Zyprexa Intramuscular (Eli Lilly) – Appearance Abnormality (2021)

cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.

Class II

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Moderate

FDAJun 29, 2021IN, MS, OH• Eli Lilly & Company

Black Rifle Coffee Mac V (Black Rifle) – Possible Plastic Contamination (2021)

Possible plastic within final product packaging.

Class IIILow

FDAJun 29, 2021TN• Black Rifle Coffee Company

Cutting Electrode (Richard Wolf) – Mislabeled Product (2021)

Laceration Risk

Product labeled as Cutting Electrode may contain BIVAP electrode.

Low

FDAJun 25, 2021Nationwide• Richard Wolf GmbH Pforzheimer Str. 32 Knittlingen Germany

OPTI SARS-CoV-2 RT-PCR Test (OPTI Medical Systems) – False Positive Risk (2021)

The firm identified a precipitation issue which may cause late Ct reactors (a false positive result) with a rate of 5 to 10% for affected vials of RNA Master Mix.

High

FDAJun 25, 2021AL, CT, FL +7 more• OPTI Medical Systems, Inc

Dole Blueberries (Dole) – Cyclospora Risk (2021)

Canadian Food Inspection Agency tested blueberries and found Cyclospora cayetanensis.

Class IIModerate

FDAJun 25, 2021AR, IL, WI• Dole Fresh Fruit Company

Jersey Cookie Monster Ice Cream (Greenwood) – Undeclared Soy (2021)

Undeclared Soy

During an FDA inspection the firm was notified that their ingredient statement does not include soy. Undeclared soy in ice cream

Class IIModerate

FDAJun 24, 2021AL, GA, NC +2 more• Greenwood Ice Cream

Kaluza C Flow Cytometry Software (Beckman Coulter) – Result Generation Error (2021)

Software anomalies that may lead to the generation of erroneous results.

Moderate

FDAJun 23, 2021Nationwide• Beckman Coulter, Inc.

Hartley's Worcestershire Sauce (H & H) – Undeclared Fish (2021)

Undeclared Allergen

Undeclared allergen: FISH (anchovies) on product labeling.

Class IHigh

FDAJun 23, 2021AL, FL, GA +1 more• H & H Products Company

Cummins ISL (Cummins) – Fuel System Concern (2021)

Fire/Burn Risk

Cummins, Inc. (Cummins) is recalling certain ISL remanufactured diesel engines sold as replacement equipment. Please see the Part 573 report for a full list of part numbers. The sealing washer may not seat correctly in the pilot bore holes, allowing the high pressure fuel rail assembly to leak.

High

NHTSAJun 22, 2021Nationwide• CUMMINS

MYLA Software (BioMerieux) – Result Alteration Risk (2021)

Software anomaly - Under certain conditions, unwanted alterations to results could be applied when using the BCI Connect scripting feature.

Moderate

FDAJun 22, 2021Nationwide• BioMerieux SA Chemin De L'Orme Marcy L'Etoile France

Limar Hand Sanitizer (Ardil) – Misleading Packaging (2021)

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

Class IHigh

FDAJun 22, 2021IN• Ardil Comercial S.R.L.

HysteroLux Fluid Management System (WOM World of Medicine) – Display Freeze Issue (2021)

When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.

Moderate

FDAJun 18, 2021Nationwide• WOM World of Medicine AG Salzufer 8 Berlin Germany

Ilizarov Wire Tensioner (Medicalplastic) – Manufacturing Error (2021)

Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error. An internal washer of the Ilizarov Wire Tensioner has been made in a wrong plastic material that could wear and break during the sterilization process in autoclave. Consequently this could cause malfunctioning of the tensioner.

Moderate

FDAJun 17, 2021TN• Medicalplastic S.R.L. Via Saverio Mercadante

24-inch Dishwashers (Cove Appliance) – Fire Hazard (2021)

Fire/Burn Risk

This recall involves Cove Appliance 24-inch built-in residential dishwashers model numbers DW2450 and DW2450WS. The recalled dishwashers have serial numbers 20000100 through 20044445. The model number, serial number and date code are printed on the product rating plate located inside the dishwasher. "Cove" is printed on the outside of the door and on the far right side of the control panel, located on the top of the unit's door.

High

CPSCJun 16, 2021Nationwide• Cove Appliance Inc., of Madison, Wis.

Proteus 235 Proton System (Ion Beam Applications) – Popup Message Issue (2021)

Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment

Moderate

FDAJun 14, 2021Nationwide• Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium

Green Pace Chili (Pacific Meridian) – Plastic Contamination (2021)

Customer reporting finding plastic pieces in Green Pace Chili Diced 3/8" imported from Mexico.

Class IIModerate

FDAJun 14, 2021TX• Pacific Meridian Group, LLC

Host Campers Rainier (Host Campers) – Stove Safety Issue (2021)

Fire/Burn Risk

Host Industries (Host) is recalling certain 2019-2021 Mammoth, Tahoe, Rainier, and Cascade trailers equipped with Dometic 3 burner cooking stoves. The saddle valve securing bolt may be overtightened, possibly damaging the o-ring seal and causing a continuous gas leak.

High

NHTSAJun 11, 2021Nationwide• HOST CAMPERS

Bulk Salted Butter (Larsen's Creamery) – Pasteurization Compliance (2021)

ODA determined HTST recording chart out of compliance. The butter made from the pasteurized milk on 4/7/21 is being recalled.

Class IIModerate

FDAJun 11, 2021IN, OR, WA• Larsen's Creamery, Inc.