The Recall Desk
HighFDA (Devices)·Z-0582-2026·Announced 2025-12-03

Demonstration only gel recalled because it may be placed in patients

Straumann USA is recalling 61 units of Emdogain because product intended for demonstration purposes only could be placed in patients.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: product not intended for patient use could be placed in a patient, and no injuries are reported.

Plain-English summary

Emdogain, article numbers 440.230V10 and 475.132V10, from Straumann USA, is being recalled.

The recall follows the possibility for this product, which is intended for demonstration purposes only, to be placed in patients.

The recall covers 61 units. Article 440.230V10 carries lots EPZM8, HPT6, KEWN9, NAAM6 and VAW80. The product was distributed in Arizona, California, Delaware, Florida, Idaho, Missouri, Tennessee, Texas, Utah and Virginia. The FDA has classified the action as Class II.

Demonstration product is not intended to go into a patient. The enforcement record reports no injuries. Practices holding affected stock should quarantine it and follow Straumann's instructions.

The recalled product

Product
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Manufacturer
Straumann USA LLC
Category
Medical Device — Dental biologic
Hazard
Affected units
61

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

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

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

Related recalls

Same manufacturer · Straumann USA LLC

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