Coloplast Conveen Urine Collection Leg Bag — Class II medical device recall Z-0155-2015
Terminated recall by Coloplast Manufacturing US, LLC, reported 2014-11-05, distributed nationwide. Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
| Recall number | Z-0155-2015 |
|---|---|
| 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 | 2014-09-29 |
| Classified | 2014-10-30 |
| Reported by FDA | 2014-11-05 |
| Terminated | 2015-03-10 |
| Distributed | Nationwide (US) |
| Quantity | 217,540 |
| Reason classes | packaging |
| Lot numbers | 3880261, 3880268, 3932929, 3932933, 3940329, 3940332, 3949825, 3949828, 3968997, 3969002, 3997492, 3997778, 3997782, 4006822, 4019572, 4019574, 4047072, 4047075, 4056422, 4056423, 4056428, 4073930, 4073934, 4092990, 4092991, 4100228 |
Product
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
Reason for recall
Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
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-0155-2015. 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.