Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Pending LLM rewrite. Source: FDA_DEVICE Z-1255-2026.
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
- Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
- Manufacturer
- Vortex Surgical 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 (1)
- 25GA Backflush Pouch UDI 810123480470 Box UDI 810123480753 Lot 2411017
Distribution
Distributed nationwide across the United States.
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