Z-0736-2022Class II

CoolSeal Generator, REF: CSL-200-50

Name: Z-0736-2022 CoolSeal Generator, REF: CSL-200-50
Creator: Bolder Surgical, LLC
Published: 2022-01-25
License: https://open.fda.gov/license/

Bolder Surgical, LLC / initiated 2022-01-25 / Terminated / root cause: manufacturing process

FDA source

Bolder Surgical, LLC began a recall of CoolSeal Generator, REF: CSL-200-50 on 2022-01-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0736-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-25
Posted: 2022-03-08
Terminated: 2024-05-15
Recalling firm: Bolder Surgical, LLC
Product: CoolSeal Generator, REF: CSL-200-50
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 10
Distribution: US: NY, MO, DE, PA, FL OUS: Italy, Chile, UK
Product codes and lots: Serial Numbers: 00161-170, UDI: 00850346007023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0736-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0736-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-16	2022-03-08

Product code GEI

K202114Class IICoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20Bolder Surgical, LLC / cleared 2020-10-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)