🔍 RecallPedia

11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018);

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:
    11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551402573; 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016) UDI Code: 4048551226353; 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551402504; 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551226377; 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551226438; 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:

11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016); 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018); 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018); 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018);

Product Codes/Lot Numbers:

11278A2 11278AK2 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551402573; 11278AC1 N/A Flexible Ureteroscope Z17859US-A (04/2016) UDI Code: 4048551226353; 11278AC2 11278ACK2 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551402504; 11278ACU1 11278ACUK1 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551226377; 11278AU1 11278AUK1 Flexible Ureteroscope Z20615US-BA (08-2018) UDI Code: 4048551226438; All Serial Numbers manufactured/distributed since January 2018.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1067-2022

Related Recalls