The Recall Desk
HighFDA (Devices)·Z-1338-2026·Announced 2026-02-18

[pending] Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

Pending LLM rewrite. Source: FDA_DEVICE Z-1338-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

Tyvek bag seal issue which may compromise sterility of the kit.

The recalled product

Product
Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
Manufacturer
AVID Medical, Inc.

Distribution

Distributed nationwide across the United States.