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Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. Th...

FDA Recall #Z-0905-2025 — Class I — December 18, 2024

Recall #Z-0905-2025 Date: December 18, 2024 Classification: Class I Status: Ongoing

Product Description

Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.

Reason for Recall

Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.

Recalling Firm

Olympus Corporation of the Americas — Center Valley, PA

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

30,140 units

Distribution

US Nationwide Distribution

Code Information

Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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