Recall Z-0905-2025— Olympus Corporation of the Americas

Name: FDA recall Z-0905-2025
Creator: U.S. Food and Drug Administration
Published: 2024-12-18

Class I · Ongoing

Class I FDA medical device recall by Olympus Corporation of the Americas, initiated 2024-12-18. It names one FDA 510(k) clearance: K912120. 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.. Reason: 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
Classification: Class I
Status: Ongoing
Initiated: 2024-12-18
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K912120 — URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPEOlympus Corp.·cleared 1991-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.