Lower riskMedical device recall · FDA · Published March 11, 2024
Coloplast Ureteral Dilator Recall: Possible Sterility Packaging Issue
Coloplast recalls ureteral dilator products REF RBD014 with possible sterility packaging breaches. Affected units have specific lot codes; contact for remedy.
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.
Take action
Contact the company
📍Recalling firmColoplast Manufacturing US, LLC1601 W River Rd · Minneapolis, MN 55411-3431
“Coloplast Ureteral Dilator Recall: Possible Sterility Packaging Issue.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55942-coloplast-ureteral-dilator-recall-possible-sterility-packaging-issue. Based on FDA recall #Z-1463-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1463-2024%22&limit=1).
The FDA announced on March 11, 2024, that Coloplast Manufacturing US, LLC is recalling Ureteral dilator REF RBD014 due to a possible sterility issue. The agency stated the hazard was detected during facility testing.
The FDA said a possible sterility issue, such as a breach in sterile packaging, was detected in Coloplast's facility on some ureteral dilator products. This issue on the packaging was identified during testing in the company's facility.
Context
GovInfoNow's records show Coloplast Manufacturing US, LLC has four other recalls since October 23, 2020. On December 2, 2024, the company recalled Folysil Silicone Foley Catheters due to a possible sterility issue. On March 1, 2023, Coloplast Titan Touch NB Scrot Zero 18cm Prosthesis was recalled for the risk of premature pump failure. Other recent recalls of similar products include Medline Convenience Kits Recall: Potential Sterility Breach in Packaging (June 12, 2026) and Medline Convenience Kits Recall: Risk of Sterile Packaging Breach (June 12, 2026).
How to tell if you have this one
Check for lot codes 6885096 through 9360599 on the packaging. The product is identified as Ureteral dilator REF RBD014.
Brand
Coloplast
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Code
Look for lot codes listed in the recall: 6885096, 6928493, 7036982, and other specific numbers.
Where it went and when
Where it was distributed
Distributed in 8 states.
Listed by the agency
Not listed
FDA distribution: “US: GA, MS, TN, MN, AZ,N MD, LA, KS, WA” States read from FDA’s own wording; “not listed” means the notice does not name it.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1463-2024 (March 11, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1463-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.