# FDA recall Z-0736-2022

> **Bolder Surgical, LLC** · Class II · device recall initiated 2022-01-25.

## Product

CoolSeal Generator, REF: CSL-200-50

## Reason for recall

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.

## Distribution

US: NY, MO, DE, PA, FL     OUS: Italy, Chile, UK

## Key facts

- **Recall number:** Z-0736-2022
- **Recalling firm:** Bolder Surgical, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-01-25
- **Report date:** 2022-03-16
- **Termination date:** 2024-05-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0736-2022

## Citation

> AI Analytics. FDA recall Z-0736-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0736-2022. Source: US FDA. Licensed CC0.

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