Olympus colonoscope PCF-H190TL recalled for missing protective adhesive
Olympus has recalled certain repaired colonoscope models lacking protective adhesive that could fail under vibration, temperature, or severe shock loads. Affected models include the PCF-H190TL, distributed nationwide.
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 3/5 (High).
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: This is a Class II medical device recall for a structural assembly defect in a colonoscope that could affect equipment functionality. No illnesses, injuries, or reported incidents are mentioned in the source, meeting the criteria for a High severity score.
Plain-English summary
Olympus Corporation of the Americas has recalled certain repaired colonoscope models, specifically the PCF-H190TL, due to an assembly defect.
The affected units were assembled without a protective adhesive designed to shield the colonoscope from physical stress conditions including high levels of vibration, temperature fluctuations, and severe shock loads. The absence of this protective adhesive could result in device malfunction or failure when exposed to these conditions.
These colonoscope models were distributed nationwide in the United States. For information about the recall and remediation options, contact Olympus Corporation of the Americas.
The recalled product
- Product
- Colonoscope, Model Number PCF-H190TL.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1
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 (3)
- Model Number: PCF-H190TL
- UDI DI: 04953170420702
- Serial Number: 2110150
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 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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