🔍 RecallPedia

Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS

Class I - Dangerous
🏥 Medical Devices Recalled: August 13, 2024 Olympus Corporation of the Americas Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI 00821925044111 All Serial Numbers:
  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:
Olympus Corporation of the Americas
Reason for Recall:
The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS

Product Codes/Lot Numbers:

UDI 00821925044111 All Serial Numbers:

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0134-2025

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