Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial Recalled by Olympus Corporation of the Americas Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.
Affected Products
Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00
Quantity: 35 units
Why Was This Recalled?
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Olympus Corporation of the Americas
Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report