UroSeal Adjustable Endoscopic Valve — Class II medical device recall Z-0861-2015
Terminated recall by US Endoscopy Group Inc, reported 2014-12-31, distributed in FL, MO, OH, WI. Packaging non-conformance related to the integrity of the sterile pouch seal.
| Recall number | Z-0861-2015 |
|---|---|
| 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 | 2014-10-31 |
| Classified | 2014-12-23 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2015-06-01 |
| Distributed | FL, MO, OH, WI |
| Quantity | 100 units |
| Reason classes | sterility, packaging |
| Lot numbers | 1417696 |
| Model numbers | 00913410 |
Product
UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.
Reason for recall
Packaging non-conformance related to the integrity of the sterile pouch seal.
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-0861-2015. 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.