Titan NB Infra Zero Ang 16cm — Class II medical device recall Z-1365-2023
Ongoing recall by Coloplast Manufacturing US, LLC, reported 2023-04-19, distributed nationwide. A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard
| Recall number | Z-1365-2023 |
|---|---|
| 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 | 2 units |
| UPC / GTIN / UDI-DI | 05708932072595 |
| Lot numbers | 8887620, 8939124 |
| Model numbers | EN88162400 |
Product
Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
Reason for recall
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
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-1365-2023. 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.