🔍 RecallPedia

Custom Manifold Kit: 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

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): K09-02239C/00884450204313/H3111528(10/31/2027), H3157165(10/31/2027); K09-02249UP/00884450330043/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); K09-09110B/00884450279076/H3163891(3/21/2028); K09-10294A/ 00884450210000/H3169190(4/30/2027); K09-11227A/00884450210697/H3156393(2/10/2028), H3157208(2/17/2028); K09-11456B/00884450279717/H3112605(8/31/2026), H3156272(8/31/2026); K09-12123B/00884450741146/H3167049(3/2/2028); K09-13342AP/00884450548714/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); K09-13391BP/00884450752111/H3128003(10/31/2027), H3152494(7/31/2027), H3170418(10/31/2027), H3173459(10/31/2027), H3184951(3/9/2028), H3190567(8/31/2026); K09-13548/00884450582329/H3156627(2/19/2028) K09-14000A/00884450785102/H3125122(11/30/2027), H3136598(11/30/2027) K09T-12020D/00884450860007/T3147714(4/24/2027), T3163752(8/1/2027) K09T-12275B/00884450640500/T3186397(2/22/2027)
  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 Manifold Kit: 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

Product Codes/Lot Numbers:

REF/UDI-DI/Lot(Expiration): K09-02239C/00884450204313/H3111528(10/31/2027), H3157165(10/31/2027); K09-02249UP/00884450330043/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); K09-09110B/00884450279076/H3163891(3/21/2028); K09-10294A/ 00884450210000/H3169190(4/30/2027); K09-11227A/00884450210697/H3156393(2/10/2028), H3157208(2/17/2028); K09-11456B/00884450279717/H3112605(8/31/2026), H3156272(8/31/2026); K09-12123B/00884450741146/H3167049(3/2/2028); K09-13342AP/00884450548714/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); K09-13391BP/00884450752111/H3128003(10/31/2027), H3152494(7/31/2027), H3170418(10/31/2027), H3173459(10/31/2027), H3184951(3/9/2028), H3190567(8/31/2026); K09-13548/00884450582329/H3156627(2/19/2028) K09-14000A/00884450785102/H3125122(11/30/2027), H3136598(11/30/2027) K09T-12020D/00884450860007/T3147714(4/24/2027), T3163752(8/1/2027) K09T-12275B/00884450640500/T3186397(2/22/2027)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2295-2025

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Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029

Merit Medical Systems

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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.

Jun 5, 2025 Other Medical Devices Nationwide View Details →