Z-0905-2025Class I

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

Name: Z-0905-2025 Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is...
Creator: Olympus Corporation of the Americas
Published: 2024-12-18
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-12-18 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel... on 2024-12-18. FDA classified it as Class I and gives the reason as "Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0905-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-12-18
Posted: 2025-01-16
Recalling firm: OLYMPUS Corporation of the Americas
Product: 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.
Product code: FBN Choledochoscope And Accessories, Flexible/Rigid
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
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.
Quantity in commerce: 30,140 units
Distribution: US Nationwide Distribution
Product codes and lots: Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0905-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0905-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-16

Product code FBN

K912120Class IIUrf-P2 Ureterorenofiberscope/choledochofiberscopeOlympus Corp. / cleared 1991-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)