SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot number: B000000166
  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:
Medtronic
Reason for Recall:
Handle may break during use.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

SharkCore LG Fine Needle Biopsy System (19GA); Material/Part#: DSL-19-01

Product Codes/Lot Numbers:

Lot number: B000000166

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1475-2017

Related Recalls

In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

Jun 18, 2025 Infusion Pumps Nationwide View Details →

In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.

Jun 18, 2025 Infusion Pumps Nationwide View Details →