🔍 RecallPedia

BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476

Class I - Dangerous
🏥 Medical Devices Recalled: June 3, 2021 Axonics Modulation Technologies Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA
  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:
Axonics Modulation Technologies, Inc.
Reason for Recall:
Lack of Sterility Assurance; needle in procedure pack labeled as sterile may not have been adequately sterilized
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

BULKAMID, URETHRAL BULKING SYSTEM model # 50050 containing the component: Bulkamid Needle, REF 230651221C, 2 G x 12 am, sterile, CE 0476

Product Codes/Lot Numbers:

Lot numbers: 19F0901AA, 19F0902AA, 19F0903AA, 19F0904AA, 19F0905AA, 19F0906AA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2077-2021