Class II — Spes Medica
| Recalling firm | Spes Medica S.p.A. |
|---|---|
| Registered facility | SPES MEDICA S.P.A (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization. |
| Product | SNS Disposable Urethral Catheter Electrode, 14 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE002 |
| Quantity | 30 boxes |
| Distribution | Distribution in the following US states: CA, MA, and SC. |
| Initiated | 2021-04-08 |
| Classified | 2021-06-25 |
| Terminated | 2022-05-10 |
| Recall number | Z-1970-2021 |
| 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 — Spes Medica (Z-1970-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87999/
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