WAVES WCM Kidney Cassette Module — Class II medical device recall Z-1013-2022
Terminated recall by Waters Medical Systems LLC, reported 2022-05-04, distributed in TN. There is a potential for the WCM cassette pump head leaking solution.
| Recall number | Z-1013-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Waters Medical Systems LLC, Rochester, MN, United States |
| Recall initiated | 2022-03-21 |
| Classified | 2022-04-27 |
| Reported by FDA | 2022-05-04 |
| Terminated | 2024-08-16 |
| Distributed | TN |
| Countries outside the US | FR |
| Quantity | 75 cases |
| Reason classes | packaging |
| Lot numbers | 123, 124, 126 |
| Expiration dates | 2022-07-01, 2023-01-05, 2023-05-17 |
Product
WAVES WCM Kidney Cassette Module
Reason for recall
There is a potential for the WCM cassette pump head leaking solution.
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-1013-2022. 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.