Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CoolSeal Generator Recalled by Bolder Surgical, LLC Due to A potential manufacturing/assembly defect could result in the...
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 Bolder Surgical, LLC directly.
Affected Products
CoolSeal Generator, REF: CSL-200-50
Quantity: 10
Why Was This Recalled?
A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially, under specific conditions, lead to the delivery of unintended energy to the patient.
Where Was This Sold?
This product was distributed to 5 states: DE, FL, MO, NY, PA
About Bolder Surgical, LLC
Bolder Surgical, LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report