Titan 0-Deg Scrotal 20 Cm — Class II medical device recall Z-1374-2023
Ongoing recall by Coloplast Manufacturing US, LLC, reported 2023-04-19, distributed nationwide. XXX
| Recall number | Z-1374-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Coloplast Manufacturing US, LLC, Minneapolis, MN, United States |
| Recall initiated | 2023-03-01 |
| Classified | 2023-04-12 |
| Reported by FDA | 2023-04-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, DE, ES, FR, GB, IT, PT, TR |
| Quantity | 20 units |
| UPC / GTIN / UDI-DI | 05708932487368 |
| Lot numbers | 8849600, 8849601, 8849621 |
| Model numbers | ES89202400 |
Product
Titan 0-Deg Scrotal 20 Cm, Catalog Number ES89202400; inflatable penile Prosthesis
Reason for recall
XXX
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-1374-2023. 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.