CLASS II Device recall · Reported 31 Dec 2014 · FDA Enforcement Report
UroSeal Adjustable Endoscopic Valve recalled by US Endoscopy Group
US Endoscopy Group is recalling UroSeal Adjustable Endoscopic Valve, distributed in Florida, Missouri, Ohio, Wisconsin. The recall was initiated on 31 Oct 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0861-2015
- FDA event ID
- 69809
- Recalling firm
- US Endoscopy Group, Mentor, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Oct 2014
- FDA classified
- 23 Dec 2014
- Reported
- 31 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 31 Oct 2014 | Recall initiated by company | |
| 23 Dec 2014 | Classified by FDA | +53 days |
| 31 Dec 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Packaging non-conformance related to the integrity of the sterile pouch seal.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Distributed to the states of FL, MO, OH and WI.
Questions about this recall
Is UroSeal Adjustable Endoscopic Valve recalled?
Yes. US Endoscopy Group recalled UroSeal Adjustable Endoscopic Valve on 31 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0861-2015.
Why was it recalled?
Packaging non-conformance related to the integrity of the sterile pouch seal.
Which lots are affected?
Lot 1417696
Where was it sold?
Distributed to the states of FL, MO, OH and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |