🔍 RecallPedia

CoolSeal Generator, REF: CSL-200-50

Class I - Dangerous
🏥 Medical Devices Recalled: January 25, 2022 Bolder Surgical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 00161-170, UDI: 00850346007023
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Bolder Surgical, LLC
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

CoolSeal Generator, REF: CSL-200-50

Product Codes/Lot Numbers:

Serial Numbers: 00161-170, UDI: 00850346007023

Distribution:

Distributed in: US, NY, MO, DE, PA, FL, UK

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0736-2022