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DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan

DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan Recalls

All product recalls associated with DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan.

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Recall Summary

Total Recalls

1000

Past Year

1000

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 2001–2020 of 21320 recalls

Aurora 4 Lighthead (DKK Dai-Ichi) – Weld Frame Crack (2024)

The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

Moderate

FDAJul 9, 2024Nationwide• DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan

Aurora 2 Lighthead (DKK Dai-Ichi) – Weld Frame Crack (2024)

The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

Moderate

FDAJul 9, 2024Nationwide• DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan

Nitrofurantoin Capsules (Sun Pharma) – Dissolution Failure (2024)

Failed Dissolution Specifications

Class II

1...99 100101102 103...1066

Page 101 of 1066Next

Moderate

FDAJul 9, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Aurora 3 Lighthead (DKK Dai-Ichi) – Weld Frame Crack (2024)

The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.

High

FDAJul 9, 2024Nationwide• DKK Dai-Ichi Shomei Co., Ltd. 1 Chome 32-26 Sakashita Itabashi Japan

Acetaminophen Injection (Hikma) – Label Mix-up (2024)

Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)

Class IHigh

FDAJul 8, 2024OH, PR• Hikma Pharmaceuticals USA Inc.

GM60A X-Ray System (NeuroLogica) – Device Arm Fall Risk (2024)

Potential for the anti-fall system of the device arm to fail.

High

FDAJul 8, 2024Nationwide• NeuroLogica Corporation

ENT Cutting Bur (Medtronic Xomed) – Expired Distribution (2024)

Product was distributed past expiration date.

Low

FDAJul 5, 2024Nationwide• Medtronic Xomed, Inc.

FRT250 Cartridge (Pega Medical) – Incorrect Component (2024)

During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of the FRT250-HEX.

Low

FDAJul 4, 2024Nationwide• ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL 1111 Chomedey (A-13) E Laval Canada

Sensis Vibe System (Siemens) – Documentation Functionality (2024)

If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.

Low

FDAJul 3, 2024Nationwide• Siemens Medical Solutions USA, Inc

VITROS Folate Reagent Pack (Ortho-Clinical) – Precipitation Issue (2024)

It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the pre-treatment process causing the increase in "TM5-4MB" condition codes which lead to a delay of results.

Low

FDAJul 3, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Luminos dRF Max (Siemens) – Support Arm Lowering Risk (2024)

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

High

FDAJul 2, 2024Nationwide• Siemens Medical Solutions USA, Inc

Luminos Lotus Max (Siemens) – Support Arm Lowering Risk (2024)

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

High

FDAJul 2, 2024Nationwide• Siemens Medical Solutions USA, Inc

Multitom Rax (Siemens) – Support Arm Lowering Risk (2024)

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

High

FDAJul 2, 2024Nationwide• Siemens Medical Solutions USA, Inc

Luminos Agile Max (Siemens) – Support Arm Lowering Risk (2024)

The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays

High

FDAJul 2, 2024Nationwide• Siemens Medical Solutions USA, Inc

Verapamil Hydrochloride Injection (Zydus) – Cross Contamination (2024)

Cross contamination with other products.

Class IIILow

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Verapamil Hydrochloride Injection (Zydus) – Cross Contamination (2024)

Cross contamination with other products.

Class IIILow

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Micafungin Injection (Zydus) – Cross Contamination (2024)

Cross contamination with other products

Class IIILow

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Decitabine Injection (Sun Pharma) – Microbial Count Issue (2024)

CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.

Class IIModerate

FDAJul 2, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Micafungin Injection (Zydus Pharmaceuticals) – Cross Contamination (2024)

Cross contamination with other products

Class IIILow

FDAJul 2, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

BioPince Biopsy Instrument (Argon Medical) – Packaging Breach (2024)

Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may lead to cross contamination, or the introduction of micro-organisms into the access site, which could lead to an infectious process, bacteremia, or sepsis.

High

FDAJul 2, 2024Nationwide• Argon Medical Devices, Inc