Ureteral dilator — Class II medical device recall Z-1463-2024
Ongoing recall by Coloplast Manufacturing US, LLC, reported 2024-04-10, distributed in AZ, GA, KS, LA, MD, MN, MS, TN…. A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some u
| Recall number | Z-1463-2024 |
|---|---|
| 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 | 2024-03-11 |
| Classified | 2024-04-02 |
| Reported by FDA | 2024-04-10 |
| Distributed | AZ, GA, KS, LA, MD, MN, MS, TN, WA |
| Quantity | 710 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 03600040300503 |
| Lot numbers | 6885096, 6928493, 7036982, 7092593, 7148682, 7187751, 7275918, 7326750, 7362229, 7405815, 7424892, 7440816, 7459583, 7528743, 7575957, 7742150, 7806993, 7825256, 7874646, 7948615, 8050730, 8122897, 8174950, 8210399, 8313229, 8350283, 8359041, 8442175, 8519426, 8619976, 8700201, 8864944, 8946228, 8946264, 9122793, 9122794, 9168554, 9226390, 9246177, 9360599 |
| Model numbers | RBD014 |
Product
Ureteral dilator, REF RBD014
Reason for recall
A possible sterility issue (e.g. a breach in sterile packaging) was detected in Coloplast's facility on some ureteral dilator products. This issue on the ureteral dilator packaging has been identified during testing in our facility.
Machine access
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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.