🔍 RecallPedia

Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP

Class I - Dangerous
🏥 Medical Devices Recalled: June 5, 2025 Merit Medical Systems Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    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)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Merit Medical Systems, Inc.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP

Product Codes/Lot Numbers:

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)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2296-2025

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