Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    1. Article Number: 440.230V10; UDI-DI: N/A; Lot Numbers: EPZM8, HPT6, KEWN9, NAAM6, VAW80; 2. Article Number: 475.132V10; UDI-DI: N/A; Lot Numbers: CRL56, HPHJ1;
  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:
Straumann USA LLC
Reason for Recall:
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

Product Codes/Lot Numbers:

1. Article Number: 440.230V10; UDI-DI: N/A; Lot Numbers: EPZM8, HPT6, KEWN9, NAAM6, VAW80; 2. Article Number: 475.132V10; UDI-DI: N/A; Lot Numbers: CRL56, HPHJ1;

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0582-2026

Related Recalls

A material mix-up had occurred during the manufacturing of StraumannΒΏ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.

Mar 17, 2026 Other Medical Devices Nationwide View Details β†’