The Recall Desk
Severity pendingFDA (Devices)·Z-1250-2026·Announced 2026-02-11

Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25

Pending LLM rewrite. Source: FDA_DEVICE Z-1250-2026.

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 I.D.D. Internal Delivery Device, VS0250.25
Manufacturer
Vortex Surgical Inc.

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)

  • Pouch UDI 810123480456 Box UDI 810123480739 Lot 2410044

Distribution

Distributed nationwide across the United States.