FDA Device recall Z-2295-2025
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K0…
- FDA Device
- Class II
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class II recall of Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K0… by Merit Medical Systems, citing 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 res….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2295-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-05 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| code_info | REF/UDI-DI/Lot(Expiration): K09-02239C/00884450204313/H3111528(10/31/2027), H3157165(10/31/2027); K09-02249UP/008844503…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( |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2295-2025%22
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