US Endoscopy Recalls Infinity Cytology Brushes Due to Deployment Issues
US Endoscopy is recalling 393 Infinity sampling devices because the cytology brush may be difficult to deploy through the catheter.
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 injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity issue involving a functional defect without reported harm.
Plain-English summary
US Endoscopy Group, Inc. is recalling 393 units of the Infinity sampling device, a disposable cytology brush used to retrieve cell samples in the gastrointestinal tract. The recall was initiated after the company received five complaints noting difficulty in deploying the brush through the catheter.
The affected devices were distributed worldwide, including in the United States and various international markets. The specific lot numbers involved in this recall are 49680, 50793, 50794, 50795, 52577, and 53023.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. Users should contact US Endoscopy Group for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.
- Manufacturer
- US Endoscopy Group Inc
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 393
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 (5)
- Lot numbers 49680
- 50793
- 50794
- 50795
- 52577 & 53023.
Distribution
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