🔍 RecallPedia

11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)

Class I - Dangerous
🏥 Medical Devices Recalled: April 1, 2022 Karl Storz Endoscopy Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018
  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:
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019)

Product Codes/Lot Numbers:

11005BC1 11005BCK1 Flexible Bronchoscope Z21493US-BA (06/2019) UDI Code: 04048551225738 All Serial Numbers manufactured/distributed since January 2018

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1055-2022

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