Olympus ENF-GP2 Fiberscope Recalled for Missing O Ring
Olympus is recalling 19 ENF-GP2 Rhino-Laryngo Fiberscopes because they may be missing an O ring after being repaired with an incorrect service manual.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a mechanical defect (missing O ring) that is being corrected via rework, fitting the criteria for a moderate severity recall without reported harm.
Plain-English summary
Olympus Corporation of the Americas is recalling 19 units of the ENF-GP2 Rhino-Laryngo Fiberscope. The product is indicated for use within the nasal and nasopharyngeal lumen. The recall is due to the possibility that the devices are missing an O ring, which may have occurred because they were repaired using an incorrect service manual.
The affected units were distributed nationwide in the United States, including in Florida, Michigan, New Mexico, New York, Ohio, and Oregon. There is no international distribution. The recall includes specific serial numbers listed in the agency's documentation.
Consumers and healthcare facilities should check their inventory for the affected serial numbers. Devices identified as part of this recall are subject to rework with the corrected service manual to ensure the O ring is present.
The recalled product
- Product
- ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 19
Distribution
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