Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX V
Pending LLM rewrite. Source: FDA_DEVICE Z-1249-2026.
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
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
The recalled product
- Product
- Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
- Manufacturer
- Vortex Surgical Inc.
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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