US Endoscopy Recalls UroSeal Valves Due to Sterile Seal Integrity Issues
US Endoscopy Group Inc is recalling 100 units of UroSeal Adjustable Endoscopic Valves because the sterile pouch seals may not be intact.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a packaging non-conformance (sterile seal integrity) which is a low-risk contamination issue without reported injuries, fitting the Moderate criteria.
Plain-English summary
US Endoscopy Group Inc is recalling 100 units of UroSeal Adjustable Endoscopic Valves, Model/Catalog # 00913410. The recall is due to a packaging non-conformance related to the integrity of the sterile pouch seal. The product is used to cover the opening to the biopsy/suction channel of an endoscope.
The affected units are from Lot 1417696 and were distributed to the states of Florida, Missouri, Ohio, and Wisconsin. The primary packaging is a Tyvek pouch, and the secondary package is a corrugate box containing 5 units.
Healthcare facilities should stop using the affected units and contact US Endoscopy Group Inc for instructions on return or replacement. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- 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.
- Manufacturer
- US Endoscopy Group Inc
- Affected units
- 100
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 1417696
Distribution
Related recalls
Same manufacturer · US Endoscopy Group Inc
See all →- HighUS Endoscopy Padlock Clip Recalled for Potential Esophageal Laceration Risk
FDA (Devices) · 2019-03-20
- LowUS Endoscopy Recalls Roth Net Polyp Retrieval Due to Date Mismatch
FDA (Devices) · 2017-03-15
- ModerateUS Endoscopy Recalls Vari-Safe Injection Needles Due to Incorrect Distribution
FDA (Devices) · 2016-10-26
- HighUS Endoscopy Recalls Histolock Resection Device Due to Sterility Concerns
FDA (Devices) · 2015-10-07
- HighUS Endoscopy Recalls Velocity Biopsy Valves Due to Structural Defect
FDA (Devices) · 2015-07-08
Same hazard · packaging defect
See all →- HighMD Wipe Outz Numbing Tattoo Wipes Recalled for Child Poisoning Risk
CPSC · 2026-08-27
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12