Olympus Corporation of the Americas Recalls

103 recalls found for Olympus Corporation of the Americas. Check if any of your products are affected.

Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Potential Deformity Hazard

Olympus Corporation of the Americas recalled 3,954 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall occurred due to devices that may not have undergone proper thermoforming, risking deformation and loss of performance. Healthcare providers and patients should stop using the devices immediately and follow the recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Deformation Risk

Olympus Corporation of the Americas recalled 93 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to a manufacturing flaw. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Hazardous Deformation Risk

Olympus Corporation of the Americas recalled 65,117 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. Improper thermoforming may cause the devices to deform and lose performance. Users should stop using the device immediately and follow the manufacturer’s instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Performance Risk

Olympus Corporation of the Americas recalled 7,046 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and performance loss. Healthcare providers and patients must stop using these devices immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Deformation Risk

Olympus Corporation of the Americas recalled 1,072 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall addresses devices that did not undergo proper thermoforming, risking performance failure. Healthcare providers and patients should stop using the devices immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Risk of Deformation

Olympus Corporation of the Americas recalled 1,490 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The devices may deform due to improper thermoforming, risking performance failure. Healthcare providers should immediately stop using these devices and follow recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Single Use 3-Lumen Sphincterotome Due to Performance Risk

Olympus Corporation of the Americas recalled 650 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to improper thermoforming. Healthcare providers and patients should stop using these instruments immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to High Risk of Deformation

Olympus Corporation of the Americas recalled 125 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and performance loss. Healthcare providers must stop using these devices immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Potential Performance Issues

Olympus Corporation of the Americas recalled 1,980 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall affects devices that did not undergo thermoforming, risking deformation and loss of performance. Healthcare providers must stop using these devices immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to High Hazard Risk

Olympus Corporation recalled 887 units of the Disposable Triple Lumen Sphincterotome on January 7, 2026. The devices may deform and lose performance if not properly thermoformed. The recall affects both US and international markets.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Risk of Deformation

Olympus Corporation of the Americas recalled 2,344 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform due to improper thermoforming, leading to performance issues. This recall affects units distributed worldwide, including all U.S. states.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Sphincterotome Recalled Due to Performance Risks

Olympus Corporation recalled 86,303 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to a manufacturing issue. This recall affects devices distributed worldwide, including 1,803 units in the U.S.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Single Use Sphincterotome Over Performance Risk

Olympus Corporation of the Americas recalled 12,641 Single Use Sphincterotome V devices on January 7, 2026. The devices may deform due to a manufacturing defect, posing a high risk of performance failure. Healthcare providers and patients must stop using these instruments immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Performance Risks

Olympus Corporation of the Americas recalled 1,504 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to a manufacturing issue. Healthcare providers and patients should stop using the devices immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome V Due to Deformation Risk

Olympus Corporation of the Americas recalled 30,489 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall stems from devices that failed to undergo proper thermoforming, risking deformation and performance loss. Healthcare providers and patients must stop using the device immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Risk of Deformation

Olympus Corporation of the Americas recalled 1,918 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall follows concerns that devices may deform and lose performance due to improper thermoforming. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Deformation Risk

Olympus Corporation of the Americas recalled 17,655 sphincterotomes on January 7, 2026. The devices may deform due to improper thermoforming, affecting performance. Patients and healthcare providers must stop using the devices immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Deformation Risk

Olympus Corporation of the Americas recalled 10,257 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. The recall follows reports that some devices did not undergo thermoforming, risking deformation and loss of performance during medical procedures. This recall affects both domestic and international distribution, including 274 units in the U.S.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Deformation Risk

Olympus Corporation of the Americas recalled 5,089 sphincterotomes on January 7, 2026, due to potential deformation. The devices may lose performance if they did not undergo thermoforming. Healthcare providers and patients should cease use immediately and follow recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Performance Risk

Olympus Corporation of the Americas recalled 136,037 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and loss of performance. Healthcare providers and patients must stop using the devices immediately.

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Brand Statistics

Total Recalls
103
Pages
6