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Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan

Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan Recalls

All product recalls associated with Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

127

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 3101–3120 of 25002 recalls

CYF-VH Cysto-Nephro Videoscope (Olympus) – Cleaning Brush Update (2023)

Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

Low

FDADec 4, 2023Nationwide• Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan

CYF-V2 Visera Videoscope (Olympus) – Cleaning Brush Update (2023)

Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

Low

FDADec 4, 2023Nationwide• Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan

Soltive Laser Fiber Stripper (Olympus) – Sterilization Concern (2023)

The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.

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High

FDADec 4, 2023Nationwide• Olympus Corporation of the Americas

BF-XP190 Bronchovideoscope (Olympus) – Cleaning Brush Update (2023)

Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

Low

FDADec 4, 2023Nationwide• Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan

Soltive Laser Fibers (Olympus) – Sterile Pouch Seal (2023)

Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).

Moderate

FDADec 4, 2023AK, AZ, AR +24 more• Olympus Corporation of the Americas

Liothyronine Sodium Tablets (Sun Pharma) – Impurity Concerns (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDADec 4, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

CYF-5R Cystonephrofiberscope (Olympus) – Cleaning Brush Update (2023)

Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

Moderate

FDADec 4, 2023Nationwide• Shirakawa Olympus Co., Ltd. Azaokamiyama 3-1 Oazaodakura; Nishigo-Mura Nishishirakawa-Gun Japan

Soltive Laser Fibers (Olympus) – Cleaning Instructions (2023)

Fire/Burn Risk

Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents the potential for the fiber to break during use, which may cause burns, procedure delays, prolonged surgery, and foreign body in patient.

High

FDADec 1, 2023Nationwide• Olympus Corporation of the Americas

Link Patella Glide Guide (Waldemar Link) – Mislabeled Dimensions (2023)

Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time

Low

FDANov 30, 2023Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

BrightView XCT (Philips) – Scan Motion Gap (2023)

Laceration Risk

While using Pre-Programmed Motion during an extrinsic quality assurance scan, a gap is created between the patient support and the detector, which may present a potential extremity entrapment hazard. Risk to patients may include fracture, body part loss of function/debilitation, muscle or ligament sprain or strain, laceration, crush injury, abrasion, or contusion.

High

FDANov 30, 2023Nationwide• Philips North America

GammaPod Treatment System (Xcision) – Planning Software Error (2023)

Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected

Moderate

FDANov 30, 2023Nationwide• Xcision Medical Systems, LLC

bkActiv Ultrasound System (B-K Medical) – Measurement Error (2023)

An issue on the Dual Live Compare feature on the bkActiv system could result in a measurement error.

Moderate

FDANov 30, 2023Nationwide• B-K Medical A/S Mileparken 34 Herlev Denmark

Polaris Patriot 850 MATRYX Snowmobiles - Injury Risk (2023)

This recall involves certain VINs of Polaris Model Year 2022 Patriot 850 MATRYX RMK, INDY and SWITCHBACK with electric start snowmobiles. In addition, this recall involves primary (drive) clutches sold as service parts with part number 1323613 (e-start). The recalled snowmobiles were sold in black and custom color combinations. "POLARIS" is stamped on the front side paneling of the vehicles. The VIN and Model Number are located on the right side of the vehicle's frame.

Moderate

CPSCNov 30, 2023Nationwide• Polaris Industries Inc., of Medina, Minnesota

Spectral CT 7500 (Philips) – Software Functionality (2023)

Multiple software issues that affect device functionality.

Moderate

FDANov 30, 2023Nationwide• Philips North America Llc

Polaris Patriot 9R MATRYX Snowmobiles - Injury Risk (2023)

This recall involves Polaris Model Year 2023 PATRIOT 9R MATRYX PRO RMK and PATRIOT 9R MATRYX RMK KHAOS. The recalled snowmobiles were sold in black and custom color combinations. "POLARIS" is stamped on the front side paneling of the vehicles. The VIN and model number are located on the right side of the vehicle's frame.

Moderate

CPSCNov 30, 2023Nationwide• Polaris Industries Inc., of Medina, Minnesota

BrightView Gamma Camera (Philips) – Scan Motion Gap (2023)

Laceration Risk

High

FDANov 30, 2023Nationwide• Philips North America

BrightView X Camera (Philips) – Scan Motion Gap (2023)

Laceration Risk

High

FDANov 30, 2023Nationwide• Philips North America

RX Series Copper Assay (Randox) – Carryover Testing (2023)

Randox Laboratories have released an update to the Carryover Avoidance Technical Bulletin to detail that Copper, should not be run directly after Total Protein, on the RX series instruments testing order. If copper assay is run after total protein it could lead to falsely elevated copper results.

Moderate

FDANov 29, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Cardiac Procedural Kits (American Contract) – Sterilization Issue (2023)

During an internal investigation, ACS identified that several components were "piggybacked" to ACS trays and subjected to the ACS sterilization process. There is no supporting documentation stating the "piggybacked" components were assessed to determine if they were suitable for exposure to elevated temperatures for an extended period of time and further exposure to sterilization. As a result, the piggybacked components may (1) have a loss/lack of functionality, (2) loss of drug efficacy, if applicable, and (3) may have had higher than specified EO residuals.

Moderate

FDANov 29, 2023Nationwide• American Contract Systems, Inc.

Anesthesia Procedural Kits (American Contract) – Sterilization Issue (2023)

Moderate

FDANov 29, 2023Nationwide• American Contract Systems, Inc.