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Kowa Pharmaceuticals America

Kowa Pharmaceuticals America Recalls

All product recalls associated with Kowa Pharmaceuticals America.

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Recall Summary

Total Recalls

709

Past Year

Class I (Serious)

Most Recent

Nov 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 41–60 of 709 recalls

Livalo 4mg (Kowa) – Foreign Tablets (2025)

Presence of foreign tablets/capsules

Class IIILow

FDAFeb 24, 2025OH, PA, TX• Kowa Pharmaceuticals America

Synapse PACS Software (Fujifilm) – patient age calculation (2025)

The incorrect computed patient age is showing in VX for patients less than 3 months old.

FDAFeb 11, 2025AZ, AR, CA +27 more• FUJIFILM Healthcare Americas Corporation

Single Use Guide Sheath Kit (Olympus) – radiopaque tip risk (2025)

Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.

FDAJan 15, 2025Nationwide• Olympus Corporation of the Americas

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Olympus MAJ-891 Forceps/Irrigation Plug (Olympus) – Biomaterial Retention Risk (2024)

Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.

FDADec 18, 2024Nationwide• Olympus Corporation of the Americas

LithoCrushV Mechanical Lithotriptor (Olympus) – Distal Tip Tearing (2024)

Potential for distal tip tearing of the Mechanical Lithotriptor V.

FDADec 16, 2024Nationwide• Olympus Corporation of the Americas

Thunderbeat Surgical Instrument (Olympus) – Probe Tip Damage (2024)

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

FDANov 25, 2024Nationwide• Olympus Corporation of the Americas

Duravent Silicone Tube (Olympus) – Product Mix-up (2024)

Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.

FDANov 19, 2024AL, AZ, CA +15 more• Olympus Corporation of the Americas

EVIS EXERA III Videoscope (Olympus) – disinfection compatibility issue (2024)

High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE ( GIF-1TH190 ).

FDAOct 31, 2024Nationwide• Olympus Corporation of the Americas

MONOCRYL Suture (ETHICON) – Component Mix-Up Risk (2024)

Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.

FDAOct 8, 2024AL, AK, AZ +42 more• ETHICON, INC. Calle Durango 2751 Col. Parque Industrial Americas, Juarez Juarez Mexico

Quest Spectrum 3 System (Olympus) – EMC Compliance (2024)

Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the replacement of the device. This could potentially result in a prolonged procedure and/or require additional medical intervention

FDASep 24, 2024OH• Olympus Corporation of the Americas

EVIS EXERA III Videoscope (Olympus) – Drying Procedure Clarification (2024)

To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.

FDASep 18, 2024Nationwide• Olympus Corporation of the Americas

Olympus Cystoscope Outer Sheath (Olympus) – Compatibility Statement Removal (2024)

Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.

FDASep 13, 2024Nationwide• Olympus Corporation of the Americas

EZDilate Wire Guided Balloon (Olympus) – Mislabeled Size Concern (2024)

Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch

FDASep 13, 2024CA, DE, FL +8 more• Olympus Corporation of the Americas

UroPass Ureteral Access Sheaths (Olympus) – UV Radiation Damage (2024)

Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.

FDASep 11, 2024Nationwide• Olympus Corporation of the Americas

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).

FDASep 4, 2024Nationwide• Olympus Corporation of the Americas

Endoscopic Flushing Pump (Olympus) – Function Loss Risk (2024)

During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.

FDAAug 23, 2024Nationwide• Olympus Corporation of the Americas

Gastrointestinal Videoscope (Olympus) – Color Correction Problem (2024)

It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.

FDAAug 21, 2024Nationwide• Olympus Corporation of the Americas

Jolly Rancher Popsicle (Unilever) – Undeclared Milk (2024)

Undeclared Milk

Undeclared milk

Class IHigh

FDAAug 21, 2024Nationwide• Unilever North America Supply Chain Company, LLC

Soltive Pro Laser (Olympus) - Translation Error (2024)

The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.

FDAAug 13, 2024Nationwide• Olympus Corporation of the Americas

Soltive Premium Laser (Olympus) - Translation Error (2024)

FDAAug 13, 2024Nationwide• Olympus Corporation of the Americas