FDA Device recall Z-0861-2015
UroSeal Adjustable Endoscopic Valve
- FDA Device
- Class II
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class II recall of UroSeal Adjustable Endoscopic Valve by Us Endoscopy Group, citing packaging non-conformance related to the integrity of the sterile pouch seal.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0861-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-31 |
| Published | 2014-12-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Us Endoscopy Group |
| Distribution | FL, MO, OH, WI |
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
Packaging non-conformance related to the integrity of the sterile pouch seal.
Identifiers
| code_info | Lot 1417696 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0861-2015%22
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