CLASS I ONGOING Device recall · Reported 22 Jan 2025 · FDA Enforcement Report
Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type) recalled
Olympus Corporation of the Americas is recalling Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type), distributed nationwide in the US. The recall was initiated on 18 Dec 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0905-2025
- FDA event ID
- 95898
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 18 Dec 2024
- FDA classified
- 16 Jan 2025
- Reported
- 22 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 18 Dec 2024 | Recall initiated by company | |
| 16 Jan 2025 | Classified by FDA | +29 days |
| 22 Jan 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
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.
Which lots are affected?
Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers.
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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