---
title: "Ureteral dilator, REF RBD014 — FDA record Z-1463-2024 | Is It on Recall"
description: "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 ureter"
url: https://isitonrecall.com/recall/fda-device-z-1463-2024-ureteral-dilator-ref-rbd014/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Ureteral dilator, REF RBD014 — FDA record Z-1463-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 11, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Ureteral dilator, REF RBD014
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Coloplast Manufacturing US, LLC
- **Quantity**: 710 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1463-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1463-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | 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 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Arizona](https://isitonrecall.com/state/arizona/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Kansas](https://isitonrecall.com/state/kansas/)
- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)
- [Mississippi](https://isitonrecall.com/state/mississippi/)
- [Tennessee](https://isitonrecall.com/state/tennessee/)
- [Washington](https://isitonrecall.com/state/washington/)

## Dates in the source

- **Report date**: Apr 10, 2024
- **Recall initiation date**: Mar 11, 2024
- **Center classification date**: Apr 2, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1463-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Coloplast Manufacturing US, LLC records](https://isitonrecall.com/brand/coloplast-manufacturing-us-llc/)