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.
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.
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.
The device may not meet medical electrical safety standards due to a manufacturing defect. Under specific conditions, this could lead to unintended energy delivery to the patient, potentially causing harm during surgical procedures.
Medical professionals using the CoolSeal Generator for surgical procedures are most at risk. Patients receiving treatment with this device could be affected if the generator malfunctions.
Check for the model reference CSL-200-50 on the device. Affected units have serial numbers between 00161-170 and UDI code 00850346007023.
Identify the model reference (CSL-200-50) and serial numbers (00161-170) to confirm if your device is affected.
The device may not meet medical electrical safety standards due to a manufacturing defect, so it should not be used until the recall is addressed.
Check the device for the model reference CSL-200-50 and serial numbers 00161-170 to see if it is affected. Contact Bolder Surgical for further instructions.
The recall record does not specify a replacement process or remedy.
We’ve drafted a message you can send Bolder Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0736-2022 — Bolder Surgical Bolder Surgical Hello, I own a Bolder Surgical that is covered by recall Z-0736-2022 from Bolder Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
