Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ureteral dilator Recalled by Coloplast Manufacturing US, LLC Due to A possible sterility issue (e.g. a breach in...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Coloplast Manufacturing US, LLC directly.
Affected Products
Ureteral dilator, REF RBD014
Quantity: 710 units
Why Was This 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.
Where Was This Sold?
This product was distributed to 9 states: AZ, GA, KS, LA, MD, MN, MS, TN, WA
About Coloplast Manufacturing US, LLC
Coloplast Manufacturing US, LLC has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report