The Recall Desk
HighFDA (Devices)·Z-2341-2023·Announced 2023-08-16

Olympus LF-P Tracheal Intubation Fiberscope Sterilization and Compatibility Update

Olympus is updating labeling for 686 LF-P fiberscopes to clarify they are no longer compatible with OER reprocessors and specify new 100% ETO sterilization protocol.

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 recall with no reported illnesses or injuries. The hazard is significant but theoretical: improper reprocessor equipment selection or incorrect sterilization protocols could result in inadequately sterilized devices, potentially leading to patient infection.

Plain-English summary

Olympus Corporation of the Americas is updating labeling for its Tracheal Intubation Fiberscope model LF-P. This medical device is used for endotracheal tube management during anesthesia procedures. Approximately 686 units nationwide are affected by this labeling revision.

The updated labeling clarifies that the LF-P fiberscopes are no longer compatible for reprocessing with the OER-Pro, OER-Elite, or OER-Mini endoscope reprocessors. The sterilization protocol for ETO gas sterilization has been changed from 12% ETO to 100% ETO. Additionally, the reusable manual cleaning brush has been discontinued; only single-use brushes remain compatible.

Medical facilities and operating rooms using the LF-P fiberscope should immediately review the updated compatibility information. If currently using the device with an OER reprocessor, facilities should verify correct sterilization protocols and equipment compatibility. Questions should be directed to Olympus Corporation of the Americas.

The recalled product

Product
Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Surgical Equipment / Endoscopy
Hazard
  • equipment-incompatibility
  • sterilization-protocol
  • infection-risk

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: 04953170051098 All serial numbers

Distribution

Distributed nationwide across the United States.

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