Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Optima Coil System Model Number OPTI0208CSS10 Recalled by BALT USA, LLC Due to Product pouch label does not match up with...
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 BALT USA, LLC directly.
Affected Products
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Quantity: 41 impacted devices
Why Was This Recalled?
Product pouch label does not match up with carton label
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About BALT USA, LLC
BALT USA, LLC has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report