Olympus Corporation of the Americas Recalls

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

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.

Olympus Corporation of the Americas
Devices which
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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.

Olympus Corporation of the Americas
Devices which
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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.

Olympus Corporation of the Americas
Devices which
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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.

Olympus Corporation of the Americas
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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.

Olympus Corporation of the Americas
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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.

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

Olympus ShockPulse-SE SPL-S Lithotripsy System Recalled 1,082 Units in 2026

Olympus Corporation of the Americas is recalling 1,082 ShockPulse Lithotripsy System SPL-S single-use probes worldwide. Investigations found the device’s generator may blink and fail to recognize the transducer, risking damage to the transducer plug or generator receptacle. Hospitals and clinics should stop using the device immediately and follow the recall instructions from Olympus.

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

Olympus ShockPulse-SE Lithotripsy System SPL-G Recall Impacts 1,684 Units Worldwide (2025)

Olympus Corporation of the Americas is recalling 1,684 ShockPulse-SE Lithotripsy System generators worldwide, including SPL-G models. Investigations found the generator can blink and fail to recognize the transducer, and damage to the transducer plug or generator receptacle may occur. Healthcare providers and patients should stop using the device immediately and follow recall instructions provided

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

Olympus Recalls Inner Sheath Due to Breaking Ceramic Tip Hazard

Olympus Corporation of the Americas recalled 1,141 units of the Inner Sheath, Model No. WA22017T, on November 11, 2025. The recall follows reports of the ceramic tip breaking, posing a high risk to patients. Healthcare providers and patients must stop using the device immediately and follow the manufacturer’s instructions.

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

Olympus Resection Sheath Recalled Due to Breakage Risk

Olympus Corporation recalled 29 units of its Resection Sheath on November 11, 2025. The recall affects model numbers A22014A and A22014T due to complaints of the ceramic tip breaking. The company advises immediate cessation of use and adherence to recall instructions.

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

Olympus Resection Sheath Recalled Due to Breaking Tips

Olympus Corporation of the Americas recalled 1,676 units of Resection Sheath Model No. A22042A on November 11, 2025. Complaints indicated the ceramic tip of the sheath could break during use, posing a hazard to patients. Healthcare providers and patients must 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 Resection Sheath Recalled Due to Breakage Hazard

Olympus Corporation of the Americas recalled the Resection Sheath Model A2666T on November 11, 2025. The recall follows reports of the ceramic tip breaking, posing a high hazard for patients. Healthcare providers and patients should stop using the device immediately.

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

Olympus Recalls Endoscopic Sheath Due to Breakage Risk

Olympus Corporation of the Americas recalled 91 units of the Inner Sheath Model No. A4741 on November 11, 2025. The recall follows reports of the ceramic tip breaking, posing a high risk to patients. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

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

Olympus Resection Sheath Recalled Due to Ceramic Tip Breakage

Olympus Corporation recalled 899 units of the Resection Sheath Model No. A42011A on November 11, 2025. Complaints indicate that the ceramic tip may break during use, posing a high risk to patients. Healthcare providers and patients must stop using the device immediately.

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

Olympus Resection Sheath Recalled Due to Ceramic Tip Breaking

Olympus Corporation of the Americas recalled 1,634 units of the A22042T Resection Sheath on November 11, 2025. The recall follows complaints of the ceramic tip breaking, posing a high risk to patients. Healthcare providers and patients must stop using the device immediately.

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

Olympus Resection Sheath Recalled Due to Breaking Hazard

Olympus Corporation of the Americas recalled 207 units of its Resection Sheath, Model No. A22043T, on November 11, 2025. The recall follows reports of the ceramic tip breaking, posing a serious hazard. Patients and healthcare providers must stop using the device immediately.

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

Olympus Resection Sheath Recalled Due to Breaking Tip Hazard

Olympus Corporation of the Americas recalled 2,626 units of its Resection Sheath on November 11, 2025. The ceramic tip of the sheath may break during use, posing a high risk to patients. Healthcare providers and patients must stop using the device immediately.

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

Olympus Inner Sheath Recalled Due to Breakage Risk

Olympus Corporation of the Americas recalled the Inner Sheath 21 Fr., Model No. A2660T, on November 11, 2025. The recall follows reports of the ceramic tip breaking during use. Patients and healthcare providers should stop using the device immediately.

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

Olympus Resection Sheath Recalled Due to Breaking Ceramic Tip

Olympus Corporation of the Americas recalled 3,484 units of the Resection Sheath Model No. A22041A on November 11, 2025. Reports indicate the ceramic tip of the device may break during use, posing a serious hazard to patients. Healthcare providers and patients must stop using the device immediately and follow recall instructions.

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

Olympus Resection Inner Sheath Recalled Due to Breakage Risk

Olympus Corporation of the Americas recalled 7,426 units of the A22040T resection sheath on November 11, 2025. The recall follows reports of the ceramic tip breaking, posing a high hazard to patients. Healthcare providers and patients must stop using the device immediately.

Olympus Corporation of the Americas
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Brand Statistics

Total Recalls
104
Pages
6