FDAHealthJune 11, 2025
AVID Medical, Inc. — PARTIAL NEPHRECTOMY - ROBOTIC. 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
- PARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.
- Brand
- AVID Medical, Inc.
- Lot code
- No
Additional details
Model No. NIHB0035-07; UDI: 10809160404959; Kit Lot No. 1591938, 1622268, 1628944, 1632685.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 46 units.
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