🔍 RecallPedia

STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2

Class I - Dangerous
🏥 Medical Devices Recalled: November 3, 2020 GA HEALTH COMPANY LIMITED Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: 19121829 Unit UDI: 04897106951116 Box UDI: 14897106951113 Cartoon Box UDI: 24897106951110
  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:
GA HEALTH COMPANY LIMITED
Reason for Recall:
Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Water-/Suction) DISTRIBUTED BY: KEY SURGICAL 8101 WALLACE ROAD / EDEN PRAIRIE, MN 55344 / USA Product Code: EN10229.2

Product Codes/Lot Numbers:

Lot Numbers: 19121829 Unit UDI: 04897106951116 Box UDI: 14897106951113 Cartoon Box UDI: 24897106951110

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0641-2021

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