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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Merit Medical Tubing and Kits Recalled for Risk of Air Entering Patient

Agency Publication Date: August 12, 2025
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Summary

Merit Medical Systems, Inc. is recalling 18,004 units of High Pressure Tubing, Custom Tubing Kits, Custom Manifold Kits, and Custom Waste Management Kits. Over time, the high-pressure tubing in these kits may relax and partially separate from its connector, creating a void that can trap air. If these products are used during a medical procedure, the trapped air could be introduced into the patient's body. No incidents or injuries have been reported to date.

Risk

If air from the tubing is introduced into a patient, it can lead to an air embolism, which is a blockage of blood flow that can cause serious medical complications or death. The risk occurs because the tubing material can loosen its grip on the connector over time, allowing air bubbles to form in the line.

What You Should Do

  1. This recall involves various Merit Medical medical tubing and kits, including High Pressure Tubing, Custom Tubing Kits, Custom Manifold Kits, and Custom Waste Management Kits.
  2. Identify if you have the affected products by checking the catalog (REF) numbers on the packaging, which include 502211002, HP9720E/C, K04-00417, K09-02239C, and K10-00353K among others. See the Affected Products section below for the full list of affected codes.
  3. Check the lot numbers and expiration dates printed on the product labeling against the list of affected batches. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled product immediately to prevent the risk of air introduction into patients.
  5. Contact Merit Medical Systems, Inc. or your equipment distributor to arrange for the return, replacement, or correction of the affected units.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions or to report any adverse events.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: High Pressure Tubing
Model / REF:
502211002
HP9720E/C
HP9721E/C
Lot Numbers:
I3116954 (8/16/2028)
I3116059 (12/10/2027)
I3127321 (12/30/2027)
I3137220 (1/28/2028)
I3116060 (12/10/2027)
UDI:
00884450859889
00884450859896

Recall #: Z-2293-2025

Product: Custom Tubing Kit
Model / REF:
K04-00417
K04-00963
K04-01029
Lot Numbers:
I3114667 (12/10/2027)
I3147550 (1/28/2028)
H3117053 (12/14/2027)
H3138590 (1/20/2028)
H3154108 (2/10/2028)
H3154786 (2/10/2028)
H3162244 (2/19/2028)
H3166789 (3/2/2028)
H3173526 (3/23/2028)
H3117059 (12/17/2027)
H3154112 (2/10/2028)
H3159017 (2/19/2028)
H3166777 (3/9/2028)
H3181994 (4/1/2028)
UDI:
00884450046630
00884450046760
00884450148938

Recall #: Z-2294-2025

Product: Custom Manifold Kit
Model / REF:
K09-02239C
K09-02249UP
K09-09110B
K09-10294A
K09-11227A
K09-11456B
K09-12123B
K09-13342AP
K09-13391BP
K09-13548
K09-14000A
K09T-12020D
K09T-12275B
Lot Numbers:
H3111528 (10/31/2027)
H3157165 (10/31/2027)
H3116232 (8/26/2026)
H3156392 (8/31/2026)
H3173422 (8/31/2026)
H3178693 (8/31/2026)
H3190348 (3/16/2028)
H3195871 (3/31/2028)
H3205105 (4/7/2028)
H3163891 (3/21/2028)
H3169190 (4/30/2027)
H3156393 (2/10/2028)
H3157208 (2/17/2028)
H3112605 (8/31/2026)
H3156272 (8/31/2026)
H3167049 (3/2/2028)
H3119448 (10/31/2027)
H3127766 (10/31/2027)
H3152497 (1/25/2028)
H3152498 (1/25/2028)
H3157249 (1/31/2028)
H3170462 (3/7/2028)
H3196372 (3/21/2028)
H3205117 (4/5/2028)
H3128003 (10/31/2027)
H3152494 (7/31/2027)
H3170418 (10/31/2027)
H3173459 (10/31/2027)
H3184951 (3/9/2028)
H3190567 (8/31/2026)
H3156627 (2/19/2028)
H3125122 (11/30/2027)
H3136598 (11/30/2027)
T3147714 (4/24/2027)
T3163752 (8/1/2027)
T3186397 (2/22/2027)
UDI:
00884450204313
00884450330043
00884450279076
00884450210000
00884450210697
00884450279717
00884450741146
00884450548714
00884450752111
00884450582329
00884450785102
00884450860007
00884450640500

Recall #: Z-2295-2025

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

Recall #: Z-2296-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97151
Status: Active
Manufacturer: Merit Medical Systems, Inc.
Sold By: Medical facilities; Hospitals
Manufactured In: United States
Units Affected: 4 products (8040; 2779; 6327; 858)
Distributed To: Ohio, California, South Dakota, Virginia, Arizona, Montana, Texas, Michigan, Florida, Tennessee, Pennsylvania, New Jersey, Minnesota, North Dakota, Iowa, Louisiana, Utah, Kentucky, Illinois, Oklahoma, Maine, Indiana, New York, New Mexico, South Carolina, Alabama, Idaho, Connecticut, Wisconsin, Georgia, Massachusetts, North Carolina, Arkansas, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.