Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Biatain Super Non-Adhesive 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
Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Country of Origin:HU. Biatain Super Non-Adhesive dressing is primarily indicated for the treatment of high, medium and low exuding leg ulcers surrounded by fragile skin. The dressings may be used throughout the healing process to provide padding and protection for 2nd degree burns, diabetic wounds (primarily lower leg and foot), surgical wounds (left to heal by secondary intention and incisional wounds) and skin abrasions. The dressings are suitable for use under compression bandaging.
Quantity: 6
Why Was This Recalled?
Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound dressing which was mislabeled.
Where Was This Sold?
This product was distributed to 2 states: MO, RI
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