Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type).… recallZ-0905-2025 · Olympus Corporation of the Americas · initiated Dec 18, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
FDA root cause category: Labeling design
What the company is doing
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.
Recall details
- Recall number
- Z-0905-2025
- Status
- Open, Classified
- Initiated by the company
- Dec 18, 2024
- Posted by the FDA
- Jan 16, 2025
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 30,140 units
- Product code
- FBN
- FDA submissions
- K912120
- Distribution
- US Nationwide Distribution
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.
Code information (models, lots, serial numbers)
Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Forceps/Irrigation Plug (Isolated Type) MAJ-891Olympus Medical Systems Corp. · Choledochoscope and accessories, flexible/rigid1 recall1 death257 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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