US Endoscopy Recalls Vari-Safe Injection Needles Due to Incorrect Distribution
US Endoscopy is voluntarily recalling one lot of Vari-Safe Injection Needles because the lot was incorrectly distributed with different internal catheter components.
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 a voluntary precautionary action for a Class II medical device involving incorrect distribution and component variation, with no reported injuries or illnesses in the source text.
Plain-English summary
US Endoscopy Group Inc is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle. The recall involves 36 units of the sterile, single-use flexible sheath device intended for the injection of various types of media through flexible endoscopes.
The recall was initiated because the lot was identified as incorrectly distributed. The lot was assembled with internal catheter components that differ from the original Vari-Safe needle internal catheter components. The source notes that all components are dimensionally similar to the original components and have a history of use on other US Endoscopy needle products.
The affected lot is identified by Model # 00711819 and Lot 1520268. Distribution was limited to the United States (Ohio, Oregon, Washington) and internationally to Italy. The source text does not specify instructions for consumers or healthcare providers regarding the disposition of the recalled units.
The recalled product
- Product
- Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
- Manufacturer
- US Endoscopy Group Inc
- Affected units
- 36
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 (2)
- Model #: 00711819
- Lot 1520268
Distribution
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