FDA Device recall Z-0413-2022
Torosa Saline-Filled Testicular Prosthesis (Size Small)
- FDA Device
- Class II
- terminated
- Published 2021-12-29
On 2021-12-29 the FDA classified a Class II recall of Torosa Saline-Filled Testicular Prosthesis (Size Small) by Coloplast Manufacturing Us, citing product is mislabeled for size.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0413-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-09 |
| Published | 2021-12-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Coloplast Manufacturing Us |
| Distribution | US |
Product
Torosa Saline-Filled Testicular Prosthesis (Size Small)
Reason
Product is mislabeled for size.
Identifiers
| code_info | SKU# 5206102400; Catalo # (450-1325); Lot 7685283 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0413-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.