The Recall Desk
HighFDA (Devices)·Z-1125-2026·Announced 2026-01-28

[pending] Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261

Pending LLM rewrite. Source: FDA_DEVICE Z-1125-2026.

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

Inflation device handle may detach from the syringe during procedure.

The recalled product

Product
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Manufacturer
Merit Medical Systems, Inc.

Distribution

Distributed nationwide across the United States.