The Recall Desk
ModerateFDA (Devices)·Z-1762-2020·Announced 2020-04-29

Olympus Pleuravideoscope Recalled Due to Missing Compatibility Data

Olympus Corporation of the Americas is recalling 265 Pleuravideoscope Model LTF-160 units because data validating compatibility with certain endo-therapy devices was missing.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a lack of validation data regarding device compatibility, which is a documentation and safety verification issue without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Olympus Corporation of the Americas is recalling 265 units of the Olympus Pleuravideoscope, Model LTF-160. The recall covers all serial numbers and affects units distributed nationwide in the United States.

The recall was initiated because there was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. This lack of validation data represents a documentation and safety verification issue rather than a confirmed defect or reported injury.

Updated Operations Manuals are being provided to address the issue. Healthcare facilities and users should check their inventory for the affected model and refer to the updated documentation for compatibility information.

The recalled product

Product
Olympus Pleuravideoscope, Model LTF-160
Affected units
265

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)

  • All Serial numbers

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →