The Recall Desk
SevereFDA (Devices)·Z-0905-2025·Announced 2025-01-22

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Category
Medical Device — Endoscope Accessories
Hazard
  • biomaterial-retention
  • incomplete-disassembly

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.

Related recalls

Same category