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.
FDA Recall Z-0905-2025 · Posted 2025-01-16
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Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeFBN
Date Initiated2024-12-18
Product Quantity30,140 units
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.
Firm Action
Olympus notified consignees on about 12/18/2024 via letter. Consignees were instructed to utilize alternative devices to the MAJ-891 according to the provided compatibility table provided, ensure all personnel are completely knowledgeable and thoroughly trained on the content of this letter and the MAJ-891 reprocessing instructions, acknowledge receipt of the letter through the Olympus portal, https://olympusamerica.com/recall, and notify customers if the units have been further distributed. Additionally, Olympus will contact customers to schedule a mutually beneficial time for an Olympus Field Representative to visit each facility and review the contents of this letter and the MAJ-891 reprocessing instructions.
Root Cause
Labeling design
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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