ROBOTIC URO/GYN PACK. Medical convenience kit.
Pending LLM rewrite. Source: FDA_DEVICE Z-2263-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
CLEARIFY VISUALIZATION SYSTEM was inadvertently resterilized in kits, causing discoloration.
The recalled product
- Product
- ROBOTIC URO/GYN PACK. Medical convenience kit.
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Model No. RDLD050-09
- UDI: 10809160413715
- Kit Lot No. 1604510
- 1604511
- 1604512
- 1606486
- 1629590
- 1633995
- 1633997.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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