Olympus MAJ-891 Forceps Recalled for Potential Biomaterial Retention During Reprocessing
Olympus recalls the MAJ-891 endoscope forceps/irrigation plug nationwide because improper reprocessing may leave biomaterial inside the device, creating a contamination risk.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity of Severe (4) per regulatory guidance. No deaths or injuries are reported in the source material. The hazard involves potential retention of biomaterial if reprocessing procedures are not performed completely.
Plain-English summary
Olympus Corporation of the Americas is recalling the MAJ-891 Forceps/Irrigation Plug (Isolated Type) used with Olympus endoscopes. The device is designed to attach to the instrument channel port to allow irrigation and the use of therapeutic endoscopy accessories. A total of 30,140 units have been distributed nationwide in the United States.
The device is being recalled because improper reprocessing procedures may fail to completely remove and disassemble the MAJ-891, potentially leaving biomaterial trapped inside. This inadvertent retention of biological material poses a contamination risk.
Healthcare facilities, endoscopy centers, and medical professionals using this device are affected by this recall.
Users should ensure complete adherence to all reprocessing instructions, paying particular attention to full disassembly and complete removal of biomaterial. Anyone with questions about proper reprocessing procedures should contact Olympus Corporation of the Americas.
The recalled product
- 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.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 30,140
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers.
Distribution
Distributed nationwide across the United States.
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