FDA Recall Database: Class II Recall: Orca Single Use Air/Water and Suction Valves, Material… by Boston Scientific Corporation

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Boston Scientific Corporation and the affected product is described in FDA's record as: 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.. FDA's stated reason for the recall is: 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.. The recall is tracked under FDA recall number Z-2413-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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. -- and the recall number Z-2413-2026. If it matches, stop using or distributing it and contact Boston Scientific Corporation or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

Boston Scientific Corporation’s FDA history

Argus HQ has recorded 6 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 6 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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.) and recall number Z-2413-2026, then follow Boston Scientific Corporation's recall instructions.

Has Boston Scientific Corporation had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 6 total FDA actions tied to Boston Scientific Corporation, including 6 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-2413-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Related enforcement actions