Torosa Saline-Filled Testicular Prosthesis — Class II medical device recall Z-0413-2022
Terminated recall by Coloplast Manufacturing US, LLC, reported 2021-12-29, distributed nationwide. Product is mislabeled for size.
| Recall number | Z-0413-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Coloplast Manufacturing US, LLC, Minneapolis, MN, United States |
| Recall initiated | 2021-11-09 |
| Classified | 2021-12-22 |
| Reported by FDA | 2021-12-29 |
| Terminated | 2025-09-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 19 units |
| Reason classes | labeling |
| Lot numbers | 7685283 |
Product
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Reason for recall
Product is mislabeled for size.
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-0413-2022. 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.