Orca single use endoscope valves recalled over sticking suction buttons
Boston Scientific is removing Orca Sterile, Single Use Air/Water and Suction Valves because of a higher than anticipated occurrence of the suction button sticking. 9,750 units affected.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a control component that sticks during an endoscopic procedure, a risk of harm with no injuries reported in the source.
Plain-English summary
The Orca Single Use Air/Water and Suction Valve, material number (UPN) SUV-617-50, is being recalled. The valve is intended to control the air and water function on an endoscope during a gastrointestinal endoscopic procedure. The action covers 9,750 units.
Boston Scientific is initiating a medical device removal of the Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking. The FDA classified the action as Class II.
Affected product is GTIN 00840253111012, lot 38400303, expiring January 20, 2029. Distribution was nationwide in the United States. The valves are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the material number, GTIN and lot number above, quarantine it, and follow the instructions issued by Boston Scientific.
The recalled product
- Product
- Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Endoscope valve
- Affected units
- 9,750
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 (4)
- GTIN 00840253111012
- Lot 38400303
- Exp. January 20
- 2029
Distribution
Distributed nationwide across the United States.
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