Olympus Corporation of the Americas medical device recall: Olympus MAJ-891 Forceps/Irrigation Plug
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 95898
- Recall initiated
- Dec 18, 2024
- Classified by FDA
- Jan 16, 2025
- Posted in Enforcement Report
- Jan 22, 2025
- Recalling firm
- Olympus Corporation of the Americas
- Firm location
- Center Valley, PA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Dec 18, 2024. FDA classified it 29 days later, on Jan 16, 2025. Distribution reported by FDA: US Nationwide Distribution Olympus Corporation of the Americas has 145 recalls in our records.
Recalled products (1)
Z-0905-2025 Class I Ongoing
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.
Codes / lots: Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers.
Quantity: 30,140 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 95898
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.