Velocity" Biopsy Valve — Class II medical device recall Z-1943-2015
Terminated recall by US Endoscopy Group Inc, reported 2015-07-08, distributed nationwide. The company has received reports of structural non conformance at the connection between the valve body and th
| Recall number | Z-1943-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | US Endoscopy Group Inc, Mentor, OH, United States |
| Recall initiated | 2015-02-17 |
| Classified | 2015-06-30 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2015-09-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CR, CZ, DE, EG, FR, HR, ID, IN, IT, LT, LV, PH, PL, RO, SI, ZA |
| Quantity | 2,173 units |
| Lot numbers | 1401267, 1404503, 1408953, 1413362, 1417521, 1420739, 1422288, 1422747, 1424014, 1500443 |
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 exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.
Reason for recall
The company has received reports of structural non conformance at the connection between the valve body and the irrigation tube, resulting in separation of the components during use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1943-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.