Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Rostorelle L Recalled by Coloplast Manufacturing US, LLC Due to Mislabeling
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
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Quantity: 111
Why Was This Recalled?
Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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