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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

583

Class I (Serious)

91

Most Recent

Dec 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 1241–1260 of 10937 recalls

BF-P190 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.

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

CYF-V2R 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.

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

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.

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

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.

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.

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

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.

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

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

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

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

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.

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.

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

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.

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

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.

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.

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

Anesthesia 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.

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

Scoot Control R-net (mo-Vis) – Throttle Lever Stuck (2023)

In rare cases, the lever of the throttle can get temporarily stuck during the movement and does not come back to its neutral point by itself. If this happens during usage, an unwanted movement of the chair could be the result. An unwanted movement could result in damage to the wheelchair, material damage around the chair and/or injury to the user, attendant or by-standers.

FDANov 28, 2023TN, TX• mo-Vis BVBA Biebuyckstraat 15D Nevele Belgium

Fujifilm Mobile X-Ray System – Incorrect Default Settings (2023)

When the key switch is turned on, the exposure conditions are set to the default values (85kV, 1.6 mAs, approx. 0.13mGy@ SID 1m) intended for adult chest imaging. In addition, if exposure conditions are set from the console while the key switch is off, the set exposure conditions will not be reflected.

FDANov 23, 2023Nationwide• FUJIFILM Healthcare Americas Corporation

Vegan Pumpkin Pie (Willamette Valley Pie) – Foreign Object (2023)

Foreign object

Class IIModerate

FDANov 21, 2023CA, IL, IN +9 more• Willamette Valley Pie Company, LLC

NovoTHOR Light Pod (THOR) – Gas Strut Ball Stud Failure (2023)

One of the ball studs attaching a gas strut to the canopy may fail. There is potential risk of injury should a ball stud fail when someone is in the NovoTHOR and trying to open or close the canopy

FDANov 20, 2023AZ, CA, CO +14 more• THOR Photomedicine Ltd 2 Anglo Office Park Units 1 &; 67 White Lion Road Amersham United Kingdom

Calibration Serum Level 3 (Randox) – CK Total Bias (2023)

CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of up to 13%.

FDANov 20, 2023Nationwide• Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland

Leica HistoCore PEGASUS (Leica) – Tissue Processing Issue (2023)

There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.

FDANov 20, 2023Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany