CoolSeal Generator, REF: CSL-200-50 recallZ-0736-2022 · Bolder Surgical, LLC · initiated Jan 25, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Bolder Surgical, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
On 01/25/22, recall notices were hand delivered to U.S. customers and emailed to O.U.S. customers. Customers were asked to do the following: Discontinue use and return affected devices to the recalling firm, and complete and return the acknowledgment form. Customers with additional questions were encouraged to contact the recalling firm at 1-866-683-1743.
Recall details
- Recall number
- Z-0736-2022
- Status
- Terminated
- Initiated by the company
- Jan 25, 2022
- Recalling firm
- Bolder Surgical, LLC
- Quantity
- 10
- Product code
- GEI
- FDA submissions
- K202114
- Distribution
- US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
Product description
CoolSeal Generator, REF: CSL-200-50
Code information (models, lots, serial numbers)
Serial Numbers: 00161-170, UDI: 00850346007023
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CoolSeal™ Generator CSL-200-50Justright Surgical, LLC · Electrosurgical, cutting & coagulation & accessories1 recall1 death2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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