Agency classClass IIOur severity:High FDA (Devices)·Z-1943-2015·Announced 2015-07-08

US Endoscopy Recalls Velocity Biopsy Valves Due to Structural Defect

US Endoscopy Group Inc is recalling Velocity Biopsy Valves because the valve body and irrigation tube may separate during use.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that could cause component separation during use, representing a risk of harm where specific injury reports are not detailed in the source text.

Plain-English summary

US Endoscopy Group Inc is recalling 2,173 units of the Velocity Biopsy Valve, a disposable medical device used to cover the biopsy inlet port of flexible gastrointestinal endoscopes. The recall involves specific lots of the product, including 1401267, 1404503, 1408953, 1413362, 1417521, 1420739, 1422288, 1422747, 1424014, and 1500443.

The company initiated the recall after receiving reports of structural non-conformance at the connection between the valve body and the irrigation tube. This defect can result in the separation of the components during use. The FDA has classified this as a Class II recall.

The affected products were distributed worldwide, including in the United States (CA, CO, IA, MA, OH, TX, and WV) and in countries such as Brazil, France, Germany, and India. Healthcare facilities and users should stop using the affected units and contact US Endoscopy Group Inc for further instructions.

The recalled product

Product: Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and…
Manufacturer: US Endoscopy Group Inc
Category: Medical Device — Endoscopy Accessories
Hazard: structural-defect
component-separation
Affected units: 2,173

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 (11)

M/N: 00711140
Lot #'s: 1401267
1404503
1408953
1413362
1417521
1420739
1422288
1422747
1424014
and 1500443.

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Same manufacturer · US Endoscopy Group Inc

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Same hazard · structural defect