Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Silhouette Paradigm 13mm Recalled by Unomedical As Due to Tubing detachment
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 Unomedical As directly.
Affected Products
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
Quantity: 9,782,880 units
Why Was This Recalled?
Tubing detachment
Where Was This Sold?
This product was distributed to 3 states: CA, IN, PA
About Unomedical As
Unomedical As has 7 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report