---
title: "CoolSeal Generator, REF: CSL-200-50 — FDA record Z-0736-2022 | Is It on Recall"
description: "A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can potentially"
url: https://isitonrecall.com/recall/fda-device-z-0736-2022-coolseal-generator-ref-csl-200-50/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# CoolSeal Generator, REF: CSL-200-50 — FDA record Z-0736-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 25, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: CoolSeal Generator, REF: CSL-200-50
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Bolder Surgical, LLC
- **Quantity**: 10
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0736-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0736-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Serial Numbers: 00161-170, UDI: 00850346007023 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Delaware](https://isitonrecall.com/state/delaware/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)

## Dates in the source

- **Report date**: Mar 16, 2022
- **Recall initiation date**: Jan 25, 2022
- **Center classification date**: Mar 8, 2022
- **Termination date**: May 15, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0736-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Bolder Surgical, LLC records](https://isitonrecall.com/brand/bolder-surgical-llc/)