Custom Waste Management Kit: REF: K10-00353K — Class II medical device recall Z-2296-2025
Ongoing recall by Merit Medical Systems, Inc., reported 2025-08-20, distributed nationwide. High pressure tubing may relax over time causing it to partially separate from the connector resulting in a vo
| Recall number | Z-2296-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2025-06-05 |
| Classified | 2025-08-12 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 858 |
| UPC / GTIN / UDI-DI | 00884450153598, 00884450179246, 00884450239308, 00884450456767, 00884450593639, 00884450808108 |
| Model numbers | K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP |
Product
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825AP
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2296-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.