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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- 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.
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