🔍 RecallPedia

LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000

Class I - Dangerous
🏥 Medical Devices Recalled: April 1, 2024 Karl Storz Endoscopy Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    All lots. REF/UDI-DI: 8694/04048551216392, 461000/04048551164860
  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:
Karl Storz Endoscopy
Reason for Recall:
Laser surgical instruments have no specific evidence of a validated reprocessing method, therefore these instruments lack sterility assurance, so once the instruments have gone through reprocessing after use and then are used again, there is an increased risk of the patient being exposed to infection.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000

Product Codes/Lot Numbers:

All lots. REF/UDI-DI: 8694/04048551216392, 461000/04048551164860

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1809-2024

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