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.
Reported: January 22, 2025 Initiated: December 18, 2024 #Z-0905-2025
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.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 30,140 units
- Distribution
- US Nationwide Distribution
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Olympus Corporation of the Americas. Units affected: 30,140 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2025. Severity: Critical. Recall number: Z-0905-2025.
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