FDAHealthJune 11, 2025
AVID Medical, Inc. — ROBOTIC URO/GYN PACK. 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
- ROBOTIC URO/GYN PACK. Medical convenience kit.
- Brand
- AVID Medical, Inc.
- Lot code
- No
Additional details
Model No. RDLD050-09; UDI: 10809160413715; Kit Lot No. 1604510, 1604511, 1604512, 1606486, 1629590, 1633995, 1633997.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 372 units.
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