These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

2,168 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
HIGHFDA 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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HIGHFDA DEVICE

Olympus Sphincterotome Recalled Due to Deformation Risk

Olympus Corporation of the Americas recalled 7,689 Disposable Triple Lumen Sphincterotomes on January 7, 2026. The devices may deform due to inadequate thermoforming, risking performance failure during medical procedures. Healthcare providers must stop using these devices immediately and follow recall instructions.

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HIGHFDA 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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HIGHFDA DEVICE

Olympus Medical Device Recalled Over Deformation Risk

Olympus Corporation recalled 4,183 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. Devices may deform and lose performance due to inadequate thermoforming. Healthcare providers should immediately stop using the affected products and follow recall instructions.

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HIGHFDA 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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HIGHFDA DEVICE

CleverCut Sphincterotome V Recalled Due to Deformation Risk

CleverCut recalled 72,023 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. The devices may deform and lose performance due to a manufacturing issue. Healthcare providers and patients must stop using these instruments immediately.

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HIGHFDA 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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HIGHFDA 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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HIGHFDA DEVICE

Olympus Recalls Sphincterotome Over Performance Risks

Olympus Corporation of the Americas recalled 5,946 single use sphincterotomes on January 7, 2026. The devices may deform and lose performance due to improper thermoforming. Healthcare providers and patients must cease use immediately to avoid potential hazards.

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HIGHFDA 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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HIGHFDA 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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HIGHFDA 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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HIGHFDA DEVICE

Olympus Recalls Sphincterotome Due to Deformation Risk

Olympus Corporation of the Americas recalled 999 units of the Disposable Triple Lumen Sphincterotome on January 7, 2026. Devices may deform and lose performance due to improper thermoforming. Patients and healthcare providers should stop using the product immediately.

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HIGHFDA 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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HIGHFDA 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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HIGHFDA 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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HIGHFDA 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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HIGHFDA 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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HIGHFDA 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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