Olympus Corporation Of The Americas recalls Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891.…
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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 accessoriesUDI-DI 04953170063114.Model Number
What the firm 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.
DistributionShow detailsHide
US Nationwide Distribution
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0905-2025
- FDA 510(k) clearance · K912120The device's official FDA premarket clearance record
- FDA device classification · FBNOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.1500The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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