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MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK Recalls

All product recalls associated with MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK.

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Recall Summary

Total Recalls

1000

Past Year

557

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 5161–5180 of 7756 recalls

MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK: VERO Linear Accelerator System, Model Number MHI-TM2000, ...

Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (ExacTrac) with Image Angle Information Used for the 1st Port Image, for a subsequent port image fusion. As the result, ExacTrac may display a Digitally Reconstructed Radiograph (DRR) image taken from the angle for the 1st port image fusion, rather than the one taken from the angle for the intended port

Class IIModerate

FDADec 2, 2014FL, NY, OH +1 more• MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK

Clinimix E Solution (Baxter) – Sterility Concerns (2014)

Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal

Class IIModerate

FDANov 25, 2014Nationwide• Baxter Healthcare Corp.

Dasani Purified Water (Coca Cola Bottling) – potential mold (2014)

1...257 258259260 261...388

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An equipment malfunction during production that may have led to the appearance of mold in some product.

Class IIILow

FDANov 24, 2014AL, FL, GA +1 more• Coca Cola Bottling Company United, LLC

Instrumentation Laboratory Co.: HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation La...

Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white to off-white color. Vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (PT) clotting times.

Class IIModerate

FDANov 21, 2014Nationwide• Instrumentation Laboratory Co.

Boston Scientific Corporation: Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis ...

Laceration Risk

Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If this occurs, the first valve could embolize and it may be necessary to convert the patient to surgery.

Class IHigh

FDANov 19, 2014IN• Boston Scientific Corporation

Boston Scientific Corporation: Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis ...

Laceration Risk

Class IHigh

FDANov 19, 2014IN• Boston Scientific Corporation

Boston Scientific Corporation: Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis ...

Laceration Risk

Class IHigh

FDANov 19, 2014IN• Boston Scientific Corporation

Horiba Instruments Inc: Lite DM (Lite Data Manager) Software Version(s): Version...

HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of a software bug related to the potential for results received being applied to the wrong order in the Lite DM Worklist. This bug has not been seen in software versions above V2.0.0.19 IMPACT: Potential for results received being applied to the wrong order in the Lite DM Worklist. The is

Class IIModerate

FDANov 19, 2014Nationwide• Horiba Instruments Inc

Clark Laboratories, Inc. (dba,Trinity Biotech USA): Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit...

Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture Test Kit, Lot 033, the firm identified a failure of the kit to meet its labeled expiry dating of 6 months.

Class IIILow

FDANov 17, 2014CA, FL, NY +1 more• Clark Laboratories, Inc. (dba,Trinity Biotech USA)

Honey Mustard Pretzel Nuggets (Baptista's Bakery) – hidden whey (2014)

The wrong seasoning was used on the pretzels, which contains whey, that is not declared on the label.

Class IHigh

FDANov 14, 2014CA• Baptista's Bakery, Inc

Horiba Instruments, Inc dba Horiba Medical: ABX PENTRA Reagent Container, Model No. B1037307 (15 mL),...

HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm. The defect would result in a false high or false low results for HbA1c and false high results for magnes

Class IIModerate

FDANov 13, 2014Nationwide• Horiba Instruments, Inc dba Horiba Medical

2014 WABASH NATIONAL VAN Recall: PARKING BRAKE:DRIVELINE:AIR:CHAMBER

Fire/Burn Risk

Wabash National Corporation (Wabash) is recalling certain model year 2014-2016 Van Trailers manufactured December 17, 2013, to January 23, 2015, equipped with a Haldex air braking system. The affected brake actuators may have been manufactured with an incomplete attachment of the internal rubber diaphragm to the actuation mechanism. This could cause dragging or overheated brakes.

NHTSANov 12, 2014Nationwide• WABASH NATIONAL

Potassium Chloride Injection (Baxter) – Incorrect Label (2014)

Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.

Class IIModerate

FDANov 10, 2014Nationwide• Baxter Healthcare Corp.

Ion Beam Applications S.A.: adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment roo...

Two issues were identified: 1. In the release of adaPT insight v1.3.2., the kV/kV Single Source acquisition workflow was linked to a wrong geometrical calibration file, resulting in an alignment offset for this specific mode of acquisition. 2. A gantry collision incident required the IBA service team to verify the gantry alignment and protons I x-ray beams colinearity, du

Class IIModerate

FDANov 7, 2014IN, PA• Ion Beam Applications S.A.

Everything Bagels (Schwartz Brothers) – mislabeled milk (2014)

Mislabeling. Product inside a plastic bag actually contains milk but mis-labeled as "Everything Bagels" and this label does not declare milk.

Class IIModerate

FDANov 6, 2014IN, OR, WA• Schwartz Brothers Restaurants dba Schwartz Brothers Bakery

Abbott Medical Optics Inc (AMO): Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3...

AMO has received complaints where the finger grip dislodged while depressing the syringe plunger. The finger grip dislodgement could result in the surgeon's hand unintentionally moving the cannula further than intended, resulting in potential trauma to the eye.

Class IIModerate

FDANov 6, 2014Nationwide• Abbott Medical Optics Inc (AMO)

Gambro Renal Products Inc: Polyflux Revaclear Max Dialyzer, Model Number 110634. ...

Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.

Class IIModerate

FDANov 5, 2014Nationwide• Gambro Renal Products Inc

2013 WABASH NATIONAL VAN Recall: SUSPENSION

Wabash National Corporation (Wabash) is recalling certain model year 2013 Van trailers manufactured September 20, 2013, to November 30, 2013, equipped with certain 2013 Pivot Bolts Part Number 93201070 manufactured by SAF-Holland. The affected pivot bolts are susceptible to cracking.

NHTSANov 5, 2014Nationwide• WABASH NATIONAL

Toshiba American Medical Systems Inc: Cardiac Function Analysis Software Product Data No. MPDC...

Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curve generated based on some of those parameters.

Class IIModerate

FDANov 5, 2014Nationwide• Toshiba American Medical Systems Inc

Gambro Renal Products Inc: Polyflux Revaclear Dialyzer, Model Number 110633. The ...

Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.

Class IIModerate

FDANov 5, 2014Nationwide• Gambro Renal Products Inc