DAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.
Pending LLM rewrite. Source: FDA_DEVICE Z-2244-2025.
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
- DAVINCI TRUCUSTOM BUNDLE. 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 (20)
- 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.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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