GS ENDOSCOPY PACK. Medical convenience kit.
Pending LLM rewrite. Source: FDA_DEVICE Z-2249-2025.
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
- GS ENDOSCOPY 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 (17)
- Model No. NAMC421-10
- NAMC421-11
- NAMC421-12
- UDI: 10809160374597
- 10809160417539
- 10809160435779
- Kit Lot No. 1584375
- 1588403
- 1605341
- 1615427
- 1615428
- 1627706
- 1628153
- 1628008
- 1628009
- 1628647
- 1632992.
Distribution
Distributed in 7 states:
- CA
- IL
- MD
- OH
- PA
- TX
- WA
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