FDA Device recall Z-1341-2013
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark
- FDA Device
- Class II
- terminated
- Published 2013-05-29
On 2013-05-29 the FDA classified a Class II recall of Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark by Coloplast Manufacturing Us, citing coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1341-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-12 |
| Published | 2013-05-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Coloplast Manufacturing Us |
| Distribution | US |
Product
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Reason
Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.
Identifiers
| code_info | 3483171 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Coloplast Manufacturing Us
- X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6…
FDA Device · Class II · 2025-01-22 · Coloplast Manufacturing Us - Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124,…
FDA Device · Class II · 2025-01-22 · Coloplast Manufacturing Us - Ureteral dilator, REF RBD014
FDA Device · Class II · 2024-04-10 · Coloplast Manufacturing Us - Titan NB Scrotal Zero Ang 18cm, Catalog Number EN88182400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us - Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400
FDA Device · Class II · 2023-04-19 · Coloplast Manufacturing Us
All Coloplast Manufacturing Us recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1341-2013%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.