FDA Medical devices recall ·
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type) recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0905-2025
- Date
- (initiated December 18, 2024)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 30,140 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers.
Distribution
US Nationwide Distribution
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0905-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.