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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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