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 Everest Bipolar Cutting Forceps 3005 Recalled for Jaw Break Risk in 2026

Olympus Corporation of the Americas is recalling 106 Everest Bipolar Cutting Forceps worldwide. The devices can have welding defects that may cause the jaw to break during use. Stop using immediately and contact Olympus or your healthcare provider for instructions.

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

Olympus Recall: 93 PKS Cutting Forceps Over Welding Defects (2026)

Olympus Corporation of the Americas recalled 93 PKS Cutting Forceps worldwide due to welding defects that can cause the jaw to break during clinical use. The issue involves Model 3005PK and UDI 00821925036000. Action is required immediately and providers should follow recall instructions.

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

Olympus PKS Cutting Forceps 920000PK Recalled Worldwide in 2026 for Welding Defects

Olympus recalls 7 PKS Cutting Forceps worldwide because welded components may fail. The devices are used with a 5mm cannula and an electrosurgical generator. Stop using the device and follow the manufacturer’s recall instructions. Healthcare facilities should verify device details and consult Olympus for replacement options.

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

Olympus MAJ-1444 Endoscope Air/Water Valve Recall 2026 for 89,579 Units

Olympus Corporation of the Americas is recalling 89,579 MAJ-1444 endoscope air/water valves distributed nationwide in the United States. The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Healthcare facilities should stop using the devices immediately and follow the manufacturer’s recall instructions.

Olympus Corporation of the Americas
The MAJ-1443
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Health & Personal Care
HIGH
FDA DEVICE

Olympus MAJ-1443/MAJ-1444 Endoscope Suction Valves Recalled in 2026

Olympus Corporation of the Americas recalls 47,383 MAJ-1443 and MAJ-1444 endoscope suction valves distributed nationwide in the United States. The valves are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Hospitals and clinics should stop using the valves immediately and follow the manufacturer’s recall instructions.

Olympus Corporation of the Americas
The MAJ-1443
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Health & Personal Care
HIGH
FDA DEVICE

Olympus OER-Pro Endoscope Reprocessor Recall for 3,354 Units Over MAJ-1443/1444 Compatibility (2026)

Olympus Corporation of the Americas recalled 3,354 units of the OER-Pro endoscope reprocessor on February 12, 2026. MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Hospitals and clinics should stop using the device immediately and follow the manufacturer’s recall instructions.

Olympus Corporation of the Americas
The MAJ-1443
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Endoscope Reprocessor OER-Elite Recall Affects 2,929 Units (2026)

Olympus Corporation of the Americas is recalling 2,929 units of the OER-Elite Endoscope Reprocessor in the United States. The MAJ-1443 and MAJ-1444 modules are no longer reprocessing compatible with the OER-Pro and OER-Elite systems. Hospitals and healthcare providers should stop using the affected devices immediately and follow the recall instructions issued by Olympus.

Olympus Corporation of the Americas
The MAJ-1443
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Insufflation Unit Recalled Due to Overpressure Hazard

Olympus Corporation recalled 744 High Flow Insufflation Units on January 16, 2026. A software algorithm issue may lead to overpressure events during use. Patients and healthcare providers must stop using the device immediately.

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

Olympus Insufflation Unit Recalled Over Software Malfunction

Olympus Corporation recalled 485 units of the High Flow Insufflation Unit, Model UHI-3, on January 16, 2026. The recall follows reports of a software algorithm issue that may cause overpressure events. Patients and healthcare providers must stop using the device immediately.

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

Olympus Insufflation Unit Recalled Due to Software Hazard

Olympus Corporation recalled 18 High Flow Insufflation Units on January 16, 2026, due to a software issue that can cause overpressure events. The recall affects model number UHI, which is used for laparoscopic 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 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.

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

Olympus Recalls Sphincterotome Due to Performance Risks

Olympus Corporation of the Americas recalled 886 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall follows reports that devices not properly thermoformed could deform and lose performance. Patients and healthcare providers should stop using the device immediately.

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

Olympus Recalls Sphincterotome Due to Performance Risk

Olympus Corporation of the Americas recalled 33,433 units of its Single Use 3-Lumen Sphincterotome V on January 7, 2026. Devices that did not undergo thermoforming may deform and lose performance, posing a high risk to patients. Healthcare providers and patients should stop using the device immediately.

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
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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 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 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
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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
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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.

Olympus Corporation of the Americas
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