🔍 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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