FDA Device recall Z-2296-2025
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
- FDA Device
- Class II
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class II recall of Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP 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-2296-2025 |
| 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 Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
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): K10-00353K/00884450179246/H3127803(1/4/2028), H3166061(2/24/2028), H3172299(3/14/2028); K10…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) |
|---|
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-2296-2025%22
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