Use caution Medical device recall · FDA · Published January 25, 2022

Bolder Surgical CoolSeal Generator Recall: Potential Unintended Energy Delivery Risk

Bolder Surgical recalls CoolSeal Generator REF CSL-200-50 due to potential manufacturing defect causing unintended energy delivery to patients. Affected units have specific serial numbers and UDI codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0736-2022Medical device Bolder Surgical ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmBolder Surgical, LLC331 S 104th St, Suite 200 · Louisville, CO 80027-9713

✎ GovInfoNow plain-language explainer

Bolder Surgical is recalling their CoolSeal Generator (REF: CSL-2:00-50) because a manufacturing defect might cause unintended energy delivery to patients during use. This could pose a risk to patient safety if the device malfunctions under specific conditions. Read more at govinfonow.com/recall/61222-bolder-surgical-coolseal-generator-recall-potential-unintended-energy-delivery-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/61222-bolder-surgical-coolseal-generator-recall-potential-unintended-energy-delivery-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0736-2022

Cite this page

“Bolder Surgical CoolSeal Generator Recall: Potential Unintended Energy Delivery Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61222-bolder-surgical-coolseal-generator-recall-potential-unintended-energy-delivery-risk. Based on FDA recall #Z-0736-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0736-2022%22&limit=1).

Bolder Surgical, LLC voluntarily recalled the CoolSeal Generator (REF: CSL-200-50) on Jan. 25, 2022, according to the FDA. The device may deliver unintended energy to patients due to a manufacturing defect. Owners should contact the company for a replacement.

How to tell if you have it

Brand: Bolder Surgical
Product: CoolSeal Generator
REF: CSL-200-50
Serial Numbers: 00161-170
UDI: 00850346007023

The hazard

A potential manufacturing or assembly defect could cause the generator to fail IEC 60601 standards. This defect may lead to the delivery of unintended energy to the patient under specific conditions.

Context

GovInfoNow's records show other recent recalls of similar medical devices include the Philips Allura Xper FD10F Medical System Recall (2025-12-15) and the Philips Allura Xper FD10C Medical System Recall (2025-12-15). Additional recent recalls include the GE Healthcare Carestation Anesthesia System Power Board Recall (2025-11-14).

How to tell if you have this one

Check for the model reference CSL-200-50 on the device. Affected units have serial numbers between 00161-170 and UDI code 00850346007023.

Brand
Bolder Surgical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Identify the model reference (CSL-200-50) and serial numbers (00161-170) to confirm if your device is affected.

Where it went and when

Where it was distributed

Distributed in 5 states, and outside the U.S.

FDA distribution: “US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Delaware, Florida, Missouri, New York, Pennsylvania.

Recall timeline

FDA terminated this recall 2.3 years after the firm started it.

Jan 25, 2022Firm started the recall
Mar 8, 2022FDA classified it Class II
Mar 16, 2022Published in FDA’s Enforcement Report
May 15, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Bolder Surgical recalls

Link to this recall

<a href="https://govinfonow.com/recall/61222-bolder-surgical-coolseal-generator-recall-potential-unintended-energy-delivery-risk">Bolder Surgical CoolSeal Generator Recall: Potential Unintended Energy Delivery Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0736-2022 (January 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0736-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.