Class II — Waters Medical Systems LLC
| Recalling firm | Waters Medical Systems LLC |
|---|---|
| Registered facility | WATERS MEDICAL SYSTEMS, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is a potential for the WCM cassette pump head leaking solution. |
| Product | WAVES WCM Kidney Cassette Module |
| Quantity | 75 cases (6ct) |
| Distribution | WCM cassettes have been distributed to one domestic customer with two locations in Tennessee and one international distributor located in France. |
| Initiated | 2022-03-21 |
| Classified | 2022-04-27 |
| Terminated | 2024-08-16 |
| Recall number | Z-1013-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Waters Medical Systems LLC (Z-1013-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89841/
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