SNS Disposable Urethral Catheter Electrode — Class II medical device recall Z-1970-2021
Terminated recall by Spes Medica, reported 2021-07-07, distributed in CA, MA, SC. The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide steri
| Recall number | Z-1970-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Spes Medica, Genoa, N/A, Italy |
| Recall initiated | 2021-04-08 |
| Classified | 2021-06-25 |
| Reported by FDA | 2021-07-07 |
| Terminated | 2022-05-10 |
| Distributed | CA, MA, SC |
| Quantity | 30 boxes |
| Reason classes | chemical contamination |
| Lot numbers | UR20F2699I |
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
Reason for recall
The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.
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-1970-2021. 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.