Bolder Surgical, LLC: Medical Device Recall in 2022 - (Recall #: Z-0736-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

CoolSeal Generator, REF: CSL-200-50

Product Classification:

Class II

Date Initiated: January 25, 2022

Date Posted: March 16, 2022

Recall Number: Z-0736-2022

Event ID: 89570

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.

Status: Terminated

Product Quantity: 10

Code Information:

Serial Numbers: 00161-170, UDI: 00850346007023

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated