Olympus Corporation of the Americas Recalls

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

Health & Personal Care
HIGH
FDA DEVICE

Olympus Sheath Recalled Over Risk of Ceramic Tip Breakage

Olympus recalled 94 units of its 10 Fr. endoscopic sheath on November 11, 2025, due to complaints of the ceramic tip breaking. The defect poses a high risk for patients undergoing urological procedures. Healthcare providers and patients must stop using the device immediately.

Olympus Corporation of the Americas
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Inner Sheath Recalled Due to Ceramic Tip Breakage Hazard

Olympus Corporation of the Americas recalled the Inner Sheath Model No. A2641 on November 11, 2025. The recall follows complaints of the ceramic tip breaking, posing a high risk of injury to patients. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

Olympus Corporation of the Americas
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Inner Sheath Recalled Due to Ceramic Tip Risk

Olympus recalled its Inner Sheath, Model No. A2642, on November 11, 2025, due to safety complaints. Users reported the ceramic tip of the resection sheath breaking during use. This recall affects urological applications and poses a high risk to patients.

Olympus Corporation of the Americas
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Thunderbeat Surgical Device Due to Adverse Events

Olympus Corporation of the Americas recalled 4,181 units of its Thunderbeat surgical device on October 22, 2025. Reports of adverse events prompted the removal of this device. The recall affects devices distributed worldwide, including the US, Brazil, Canada, Germany, Mexico, and Japan.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Thunderbeat Surgical Device Recalled Due to Adverse Events

Olympus Corporation of the Americas recalled 52 units of the Thunderbeat, 5 mm, 35 cm, Inline Grip on October 22, 2025. Reports of adverse events prompted the removal of this medical device from the market. The recall affects distribution in the US, Brazil, Canada, Germany, Mexico, and Japan.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Thunderbeat Surgical Device Recalled Over Adverse Events

Olympus Corporation of the Americas recalled the Thunderbeat 5 mm, 35 cm, Front-Actuated Grip on October 22, 2025. The recall follows reports of adverse events associated with the device. Healthcare providers and patients must stop using this product immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Thunderbeat Surgical Device Recalled Due to Adverse Events

Olympus Corporation of the Americas recalled 88,268 units of the Thunderbeat surgical device on October 22, 2025. The recall follows reports of adverse events associated with the device. Healthcare providers and patients should stop using the device immediately and follow the recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Thunderbeat Device Recalled Due to Adverse Events

Olympus Corporation of the Americas recalled the Thunderbeat 5 mm, 20 cm, Front-Actuated Grip on October 22, 2025. The recall follows ongoing reports of adverse events associated with the medical device. Patients and healthcare providers must stop using the device immediately and follow recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Thunderbeat Surgical Instrument Over Safety Concerns

Olympus Corporation of the Americas recalled 9,542 units of the Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S on October 22, 2025. The recall follows continued reports of adverse events associated with the device. Patients and healthcare providers must stop using it immediately and follow manufacturer instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Thunderbeat Surgical Instrument Recalled Due to Safety Concerns

Olympus Corporation of the Americas recalled the Thunderbeat, 5 mm, 45 cm Front-Actuated Grip on October 22, 2025. The recall follows ongoing reports of adverse events associated with the device. Healthcare providers and patients must stop using the instrument immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Thunderbeat Surgical Instrument Recalled Due to Hazards

Olympus Corporation recalled 3,381 units of the Thunderbeat surgical instrument on October 22, 2025. The recall follows continued reports of adverse events associated with the device. Patients and healthcare providers must stop using the product immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Thunderbeat Surgical Device Recalled Over Adverse Events

Olympus Corporation of the Americas recalled the Thunderbeat surgical device on October 22, 2025, due to reports of adverse events. The recall affects 30 units distributed worldwide, including the US, Canada, and Japan. Patients and healthcare providers must stop using the device immediately.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Thunderbeat Surgical Device Recalled Due to Hazardous Events

Olympus Corporation of the Americas recalled the Thunderbeat, 5 mm, 45 cm, Pistol Grip device on October 22, 2025. The recall affects 30 units distributed worldwide, including the U.S., Canada, Brazil, Germany, Mexico, and Japan. Patients and healthcare providers must stop using this device immediately due to reports of adverse events.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Thunderbeat Surgical Device Recalled Over Safety Concerns

Olympus Corporation of the Americas recalled 1,538 units of the Thunderbeat 5 mm, 10 cm, Inline Grip on October 22, 2025. The recall follows multiple reports of adverse events linked to the device. Healthcare providers and patients should stop using it immediately and follow the manufacturer's instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus Thunderbeat Surgical Device Recalled Due to Adverse Events

Olympus Corporation of the Americas recalled 140 units of its Thunderbeat surgical device on October 22, 2025. Users reported ongoing adverse events linked to the device. Healthcare providers should stop using it immediately and follow recall instructions.

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Health & Personal Care
HIGH
FDA DEVICE

Olympus EVIS EXERA III BF-1TH190 Bronchoscope Recall 8,587 Units in 2025

Olympus Corporation of the Americas recalls 8,587 bronchovideoscope units worldwide, including 4,297 in the US and 4,290 outside. The recall centers on updated IFU language for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Stop using the device immediately and follow manufacturer instructions for remediation.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-1T60 Bronchofiberscope Recall for IFU Updates (2025)

Olympus recalled 3,216 BF-1T60 bronchofiberscopes distributed nationwide and internationally after updating instructions for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. The recall updates guidance to reduce risk during advanced energy-device procedures. Clinicians and facilities should stop using the devices and follow manufacturer instructions for recall.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-P60 Bronchoscope Recall Affects 6,450 Units in 2025 for IFU Updates

Olympus recalled 6,450 BF-P60 bronchofiberscopes worldwide after updated instructions clarify safe use with laser, argon plasma coagulation and high-frequency therapy devices. The recall covers 1,007 US units and 5,443 units outside the US. Healthcare providers should stop using the device immediately and follow manufacturer instructions. Contact Olympus Corporation of the Americas for guidance.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-1TQ170 Bronchoscope Recall Expanded for IFU Clarifications

Olympus Corporation of the Americas recalls the BRONCHOVIDEOSCOPE BF-1TQ170. The recall is active with 2,092 units in the outside US market and no US units affected. The action seeks updated instructions for safe use with laser and high-frequency therapy equipment. Healthcare providers should stop use and follow manufacturer recall instructions.

Olympus Corporation of the Americas
Additional IFU
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Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-XT40 Bronchoscope Recall Affects 821 Units Worldwide in 2025

Olympus Corporation of the Americas issued a Class I recall for 821 BF-XT40 bronchoscopes worldwide, including 116 units in the United States and 705 outside the U.S. The recall centers on updated Instructions For Use to clarify safe and effective use with laser, argon plasma coagulation and high-frequency therapy equipment. Hospitals and clinics should stop using the devices and follow Olympus’召v

Olympus Corporation of the Americas
Additional IFU
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