🔍 RecallPedia

SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

Class I - Dangerous
🏥 Medical Devices Recalled: December 4, 2023 Olympus Corporation of the Americas Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI 00821925043985 Lot KR262848
  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:
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

Product Codes/Lot Numbers:

UDI-DI 00821925043985 Lot KR262848

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0718-2024

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