Porges Coloplast recallZ-1463-2024 · Coloplast Manufacturing US, LLC · initiated Mar 11, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Coloplast Manufacturing US, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
Coloplast issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL notice to its consignees on 03/11/2024 via USPS first class mail. The notice explained the issue and requested the consignee contact the firm ( Email: [email protected], Phone: 800-258-3476) for a refund for returned product.
Recall details
- Recall number
- Z-1463-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 11, 2024
- Posted by the FDA
- Apr 2, 2024
- Recalling firm
- Coloplast Manufacturing US, LLC
- Quantity
- 710 units
- Product code
- EZN
- FDA submissions
- K170531
- Distribution
- US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA
Product description
Ureteral dilator, REF RBD014
Code information (models, lots, serial numbers)
UDI-DI: 03600040300503, Lot codes: 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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Porges Coloplast RBD014Coloplast A/S · DILATOR, CATHETER, URETERAL1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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