The Recall Desk
HighFDA (Devices)·Z-2340-2023·Announced 2023-08-16

Olympus VISERA Tracheal Videoscope reprocessor compatibility and sterilization procedure revision

Olympus is revising labeling for the VISERA Tracheal Intubation Videoscope to correct equipment compatibility information and update sterilization procedures. The device is no longer compatible with OER-Pro, OER-Elite, and OER-Mini reprocessors; sterilization and cleaning procedures have changed significantly.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device used for critical airway management. The recall addresses equipment compatibility changes and updated sterilization procedures; improper reprocessing could compromise device sterility and patient safety. No illnesses or injuries have been reported.

Plain-English summary

Olympus Corporation of the Americas is revising the labeling for the VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V (UDI-DI: 04953170340246, all serial numbers), an endoscopic device used for airway management, endotracheal and endobronchial intubation. Approximately 1,433 units were distributed nationwide.

The revised labeling indicates that the LF-V and LF-P endoscopes are no longer compatible with OER-Pro, OER-Elite, and OER-Mini endoscope reprocessor equipment. The ethylene oxide (EtO) gas sterilization conditions have been changed from 12% to 100% EtO. The reusable cleaning brush for manual cleaning is no longer compatible with the updated procedure; only single-use brushes may be used.

Healthcare facilities and clinicians using the VISERA LF Type V videoscope should immediately review and follow the revised labeling instructions for proper reprocessing and sterilization. If your facility has previously used this device with OER reprocessor equipment or different sterilization conditions, contact Olympus Corporation of the Americas for guidance on compliance with the updated requirements.

The recalled product

Product
VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V- For airway management which includes endoscopic observation to access airway anatomy, endotracheal/endobronchial intubation and management.
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Airway Management Equipment
Hazard
  • equipment-incompatibility
  • sterilization-procedure
  • labeling-error

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)

  • UDI-DI: 04953170340246 All serial numbers

Distribution

Distributed nationwide across the United States.

Related recalls

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