Recall Z-0905-2025
Olympus Corporation of the Americas · initiated December 18, 2024
Class I – dangerous or defective products that could cause serious health problems or death
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.
Codes / lots: Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers.
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.
FDA-determined cause: Labeling design
Action taken
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.
Details
- Recall number
- Z-0905-2025
- Initiated
- December 18, 2024
- Posted by FDA
- January 16, 2025
- Product code
- FBN – Choledochoscope And Accessories, Flexible/Rigid
- Quantity
- 30,140 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA