Karl Storz Endoscope Cleaning Brush Recalled for Fit Issues
Karl Storz is recalling 16,908 endoscope cleaning brushes because they may not fit into the endoscope channel, preventing proper cleaning.
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 functional defect (inability to clean) rather than a direct physical injury or acute contamination, fitting the criteria for moderate severity.
Plain-English summary
Karl Storz Endovision, Inc. is recalling 16,908 units of the Karl Storz Flexible Cleaning Brush, Model Number 11276CL. This single-use, non-sterile device is intended for cleaning various models of endoscopes. The recall covers all lot numbers and includes units distributed nationwide as well as in Canada and Mexico.
The recall was initiated because the brush may not fit the intended endoscope. This design issue can result in an inability to insert the brush into the channel of the endoscope or to completely pass it through the channel. If the brush cannot be fully inserted or passed through, it may not clean the endoscope effectively.
Healthcare facilities and consumers who have this product should stop using it and contact Karl Storz Endovision, Inc. for further instructions or a return.
The recalled product
- Product
- ENDOSCOPE BRUSH- KARL STORZ Flexible Cleaning Brush single-use, non-sterile device for cleaning various models of endoscopes Model Number: 11276CL
- Manufacturer
- Karl Storz Endovision, Inc.
- Affected units
- 16,908
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 lot numbers
Distribution
Distributed nationwide across the United States.
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