Bolder Surgical, LLC recalls CoolSeal Generator, REF: CSL-200-50
- Recall date
- January 25, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0736-2022
- FDA classification
- Class II
- Brand / firm
- Bolder Surgical, LLC
- Sold / distributed
- US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
Why it was 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
CoolSeal Generator, REF: CSL-200-50
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