FDA Device recall Z-2413-2026
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50
- FDA Device
- Class II
- ongoing
- Published 2026-06-17
On 2026-06-17 the FDA classified a Class II recall of Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50 by Boston Scientific, citing boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2413-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-12 |
| Published | 2026-06-17 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Boston Scientific |
| Distribution | US |
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.
Reason
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
Identifiers
| code_info | GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-09-09 · Boston Scientific
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2413-2026%22
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