FDAHealthJune 11, 2025
AVID Medical, Inc. — DAVINCI UROLOGY. 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 UROLOGY. Medical convenience kit.
- Brand
- AVID Medical, Inc.
- Lot code
- No
Additional details
Model No. WRNM038-09, WRNM038-10, WRNM038-11; UDI: 10809160369302, 10809160418338, 10809160432259; Kit Lot No. 1589886, 1593087, 1606686, 1606688, 1615262, 1611133, 1627007.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 166 units.
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