FDAHealthJune 11, 2025
AVID Medical, Inc. — DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
⚠️ CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
Is this relevant to me?
- Geography
- CA, IL, MD, OH, PA, TX, WA
- Source agency
- FDA
- Category
- Health
- Published
- June 11, 2025
Domestic: CA, IL, MD, OH, PA, TX, WA.
What's affected?
- Product
- DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
- Brand
- AVID Medical, Inc.
- Lot code
- No
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 626 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.