FDA Recalls Rhino-Laryngofiberscope Cleaning Instructions for Brush Compatibility
Shirakawa Olympus is recalling instructions for the Model ENF-XP Rhino-Laryngofiberscope. Reusable cleaning brushes have been removed from the manual cleaning procedure; single-use brushes remain compatible.
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: This is a Class II precautionary instruction update with no reported illnesses, injuries, or device failures. The hazard is theoretical—improper cleaning could affect device performance—but the company is proactively addressing the issue through updated guidance with an alternative cleaning method available.
Plain-English summary
Shirakawa Olympus Co., Ltd. is recalling instructions for the Model No. ENF-XP Rhino-Laryngofiberscope, a medical endoscope.
The company has updated the instructions for use to remove reusable cleaning brushes from the manual cleaning procedure. Single-use brushes are now the only brush type recommended for manual cleaning of the device.
Approximately 1,929 units were distributed in the United States, with an additional 2,200 distributed outside the country. Users should consult the updated instructions for use and ensure that only single-use brushes are used for manual cleaning of the device.
The recalled product
- Product
- Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE
- Manufacturer
- Shirakawa Olympus Co., Ltd.
- Hazard
- instruction-deficiency
- cleaning-procedure
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: 04953170059018 All serial numbers
Distribution
Distributed nationwide across the United States.
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