Bolder Surgical, LLC CoolSeal Generator, REF: CSL-200-50 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CoolSeal Generator, REF: CSL-200-50
Brand
Bolder Surgical, LLC
Lot Codes / Batch Numbers
Serial Numbers: 00161-170, UDI: 00850346007023
Products Sold
Serial Numbers: 00161-170, UDI: 00850346007023
Bolder Surgical, LLC is recalling CoolSeal Generator, REF: CSL-200-50 due to A potential manufacturing/assembly defect could result in the generator not meeting IEC 60601 standards for medical electrical equipment, and it can p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
DE, FL, MO, NY, PA
Page updated: Jan 10, 2026