Genesis Malleable Penile Prosthesis — Class II medical device recall Z-1538-2015
Terminated recall by Coloplast Manufacturing US, LLC, reported 2015-05-06, distributed nationwide. Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Lab
| Recall number | Z-1538-2015 |
|---|---|
| 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 | 2015-04-09 |
| Classified | 2015-04-27 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-09-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR |
| Reason classes | labeling |
| Model numbers | 91-9509SC/519250 |
Product
Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. Product Usage: The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction.
Reason for recall
Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box and Patient Labels indicate a size 9 mm, instead of 9.5 mm. The device size is printed directly on the individual prosthesis tray during the packaging process and states the correct size, 9.5 mm.
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-1538-2015. 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.