ROBOTIC URO/GYN PACK. Medical convenience kit.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Model No. RDLD050-09; UDI: 10809160413715; Kit Lot No. 1604510, 1604511, 1604512, 1606486, 1629590, 1633995, 1633997.
  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:
AVID Medical, Inc.
Reason for Recall:
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

ROBOTIC URO/GYN PACK. Medical convenience kit.

Product Codes/Lot Numbers:

Model No. RDLD050-09; UDI: 10809160413715; Kit Lot No. 1604510, 1604511, 1604512, 1606486, 1629590, 1633995, 1633997.

Distribution:

Distributed in: CA, IL, MD, OH, PA, TX, WA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2263-2025

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