Aizu Olympus recalled 6,578 OER-Elite medical devices following safety concerns. The recall, announced on October 31, 2025, urges patients and healthcare providers to stop using the device immediately. Repairs should only be conducted by trained personnel to ensure safety.
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Aizu Olympus Co., Ltd. or your healthcare provider for instructions. Notification method: Letter
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The recall affects the Olympus OER-Elite model, with a unique device identifier (UDI) of 04953170404047. The recall includes all serial numbers of the device. It was distributed nationwide in the U.S.
The recall addresses warnings and cautions associated with the OER-Elite device. Only properly trained personnel should conduct repairs and maintenance. The hazard level is classified as high.
No specific incidents have been reported, but the classification suggests a significant risk to users if the device is misused or improperly maintained.
Patients and healthcare providers should stop using the OER-Elite immediately. Follow the recall instructions provided by Aizu Olympus Co., Ltd. For further guidance, contact your healthcare provider.
For more information, visit the FDA recall page or contact Aizu Olympus Co., Ltd. directly for instructions.
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