The Recall Desk
HighFDA (Devices)·Z-2296-2025·Announced 2025-08-20

[pending] Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05

Pending LLM rewrite. Source: FDA_DEVICE Z-2296-2025.

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

High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.

The recalled product

Product
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
Manufacturer
Merit Medical Systems, 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 (18)

  • REF/UDI-DI/Lot(Expiration): K10-00353K/00884450179246/H3127803(1/4/2028)
  • H3166061(2/24/2028)
  • H3172299(3/14/2028)
  • K10-01603C/00884450593639/H3163984(3/2/2028)
  • H3176777(3/23/2028)
  • K10-01694Q/00884450239308/H3116890(10/31/2027)
  • H3152493(2/3/2028)
  • H3177622(3/14/2028)
  • K10-05159B/00884450153598/H3116922(12/23/2027)
  • H3119571(1/4/2028)
  • H3127907(1/11/2028)
  • H3152490(2/10/2028)
  • H3152491(2/10/2028)
  • H3152492(2/10/2028)
  • K10-05743/00884450456767/H3122012(1/6/2028)
  • H3128429(1/13/2028)
  • H3177446(3/16/2028)
  • K10-05825AP/00884450808108/H3112585(11/27/2027)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category