UroSeal Adjustable Endoscopic Valve. Model/Catalog #… recallZ-0861-2015 · US Endoscopy Group Inc · initiated Oct 31, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from US Endoscopy Group Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Packaging non-conformance related to the integrity of the sterile pouch seal.
FDA root cause category: Equipment maintenance
What the company is doing
Consignees were notified by phone, e-mail, and an Urgent: US Endoscopy UroSeal Adjustable Valve Recall letter. The letter identified the affected product and the reason for the recall. Customers were asked to remove any affected product from their inventory and quarantine them. Additionally, customers were to complete and return the attached Customer Response Card to Kia Pennington via fax at 1-440-639-4495 or e-mail at [email protected] as soon as possible. The firm contacted customers regarding the RMA instructions and replacement product. Customers were to follow the RMA instructions in order to receive an RMA number and return the affected product. Questions should be directed towards Kia Pennington in Customer Service at 1-800-769-8229.
Recall details
- Recall number
- Z-0861-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 31, 2014
- Posted by the FDA
- Dec 23, 2014
- Recalling firm
- US Endoscopy Group Inc
- Quantity
- 100 units
- Product code
- KOG
- FDA submissions
- K070420
- Distribution
- Distributed to the states of FL, MO, OH and WI.
Product description
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.
Code information (models, lots, serial numbers)
Lot 1417696
Other devices under the same FDA submission
3 devices cleared under K070420 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BioShield 00711126US Endoscopy · Endoscopic retrograde cholangiopancreatography (ERCP) cannula2 reports
- BioShield 00711125US Endoscopy · Endoscopic retrograde cholangiopancreatography (ERCP) cannula2 reports
- BioShield 00711133US Endoscopy · Endoscopic retrograde cholangiopancreatography (ERCP) cannula1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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