🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: December 23, 2021 Olympus Corporation of the Americas Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Olympus Corporation of the Americas
Reason for Recall:
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0551-2022

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