Coloplast Manufacturing US, LLC: Medical Device Recall in 2024 - (Recall #: Z-1463-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Ureteral dilator, REF RBD014

Product Classification:

Class II

Date Initiated: March 11, 2024

Date Posted: April 10, 2024

Recall Number: Z-1463-2024

Event ID: 94218

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.

Status: Ongoing

Product Quantity: 710 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated