🔍 RecallPedia

DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.

Class I - Dangerous
🏥 Medical Devices Recalled: June 11, 2025 AVID Medical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Model No. MAMC228-13, MAMC228-14, MAMC228-15; UDI: 10809160366943, 10809160366820, 10809160420980, 10809160421734, 10809160441046; Kit Lot No. 1576797, 1577255, 1586536, 1606044, 1607044, 1607825, 1615452, 1621487, 1621488, 1638247, 1639254, 1647833.
  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:

DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.

Product Codes/Lot Numbers:

Model No. MAMC228-13, MAMC228-14, MAMC228-15; UDI: 10809160366943, 10809160366820, 10809160420980, 10809160421734, 10809160441046; Kit Lot No. 1576797, 1577255, 1586536, 1606044, 1607044, 1607825, 1615452, 1621487, 1621488, 1638247, 1639254, 1647833.

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-2244-2025

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