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Olympus Corporation of the Americas

Olympus Corporation of the Americas Recalls

All product recalls associated with Olympus Corporation of the Americas.

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Recall Summary

Total Recalls

1000

Past Year

896

Class I (Serious)

125

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 1581–1600 of 17592 recalls

InstaClear Lens Sheath (Olympus) – Potential Breakage (2024)

Potential for distal end of the sheath to break off during a procedure.

Moderate

FDAApr 3, 2024Nationwide• Olympus Corporation of the Americas

Airvo 2 Humidifier (Fisher & Paykel) – Speaker Configuration (2024)

Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.

Moderate

FDAApr 2, 2024Nationwide• Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Place East Tamaki Auckland New Zealand

EchoTip Ultrasound Needle (Cook) – Bacterial Endotoxin Levels (2024)

Devices may contain elevated levels of bacterial endotoxin.

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Low

FDAApr 1, 2024IN• Cook Medical Incorporated

EchoTip Ultrasound Needle (Cook) – Bacterial Endotoxin Levels (2024)

Devices may contain elevated levels of bacterial endotoxin.

Low

FDAApr 1, 2024IN• Cook Medical Incorporated

Dynamic Mesh Implant (Stryker) – Mislabeling Issue (2024)

Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure

Low

FDAMar 29, 2024Nationwide• Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany

Pink Lemonde (Charles Boggini) – Undeclared Red Color (2024)

Undeclared Allergen

Products contain undeclared FD&C Red No. 40

Class IIModerate

FDAMar 29, 2024AZ, CA, CT +6 more• Charles Boggini Company Llc

Cola Flavoring Base (Charles Boggini) – Undeclared Sulfites (2024)

Undeclared Allergen

Products contain undeclared sulfites.

Class IIModerate

FDAMar 29, 2024AZ, CA, CT +6 more• Charles Boggini Company Llc

Yellow Lemonade (Charles Boggini) – Undeclared Yellow Color (2024)

Undeclared Allergen

Products contain undeclared FD&C Yellow No. 5

Class IIILow

FDAMar 29, 2024AZ, CA, CT +6 more• Charles Boggini Company Llc

RayStation 9.0 (RaySearch) – SSD Measurement Risk (2024)

Potential for reported SSD to be too high.

Low

FDAMar 28, 2024Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

RayStation 12.0 (RaySearch) – SSD Measurement Risk (2024)

Potential for reported SSD to be too high.

Low

FDAMar 28, 2024Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

RayStation 8.1 (RaySearch) – SSD Measurement Risk (2024)

Potential for reported SSD to be too high.

Low

FDAMar 28, 2024Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

Intellis AdaptiveStim (Medtronic) – Reprogramming Limitation (2024)

inability to reprogram one device

Moderate

FDAMar 28, 2024IN• Medtronic Neuromodulation

RayStation 10.0 (RaySearch) – SSD Measurement Risk (2024)

Potential for reported SSD to be too high.

Low

FDAMar 28, 2024Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

RayStation 8.0 (RaySearch) – SSD Measurement Risk (2024)

Potential for reported SSD to be too high.

Low

FDAMar 28, 2024Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

RayStation 11.0 (RaySearch) – SSD Measurement Risk (2024)

Potential for reported SSD to be too high.

Low

FDAMar 28, 2024Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

Snowmobiles with PATRIOT BOOST Engines (Polaris) – fire hazard (2024)

Fire/Burn Risk

This recall involves Polaris Model Year 2022-2023 Snowmobiles equipped with PATRIOT BOOST engines, including the Pro RMK Slash, RMK Khaos Slash, INDY VR1, and Switchback Assault. The recalled snowmobiles were sold in black and custom color combinations. "POLARIS" is stamped on the front side panel of the vehicles. The VIN and model number are located on the right side of the vehicle's frame.

High

CPSCMar 28, 2024Nationwide• Polaris Industries Inc., of Medina, Minnesota