HIGH

Straumann USA Recalls 61 Emdogain Demonstration Dental Devices (2025)

Straumann USA recalled 61 Emdogain demonstration devices distributed nationwide in 10 states. The devices, intended for demonstration only, could be placed in patients. Healthcare providers and patients should stop using immediately and follow recall instructions from Straumann for disposal or replacement.

Quick Facts at a Glance

Recall Date
October 17, 2025
Hazard Level
HIGH
Brand
Straumann
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

The possibility for this product that is intended for demonstration purposes only to be placed in patients.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Straumann USA LLC or your healthcare provider for instructions. Notification method: Letter

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About This Product

Emdogain is a dental regenerative product used in periodontal therapy. The recall concerns demonstration devices that were intended for display and training but may have been used on patients.

Why This Is Dangerous

The hazard arises when demonstration devices are used on real patients, potentially exposing them to a product not intended for patient use.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Clinicians must verify their inventories and stop use of affected devices. No injuries have been reported, but patient safety could be compromised if a demonstration device is used clinically.

Practical Guidance

How to identify if yours is affected

  1. Identify if you have Article Numbers 440.230V10 or 475.132V10
  2. Check for the listed lot numbers EPZM8, HPT6, KEWN9, NAAM6, VAW80 (440.230V10) or CRL56, HPHJ1 (475.132V10)
  3. Do not use any device that matches the above identifiers on patients

Where to find product info

Recall notices and identifiers are on the device labels and accompanying documentation. Official recall details are available from the recall notice linked in the source

What timeline to expect

Refunds or replacements are typically processed within 4-6 weeks after validation of eligibility

If the manufacturer is unresponsive

  • Document all attempts to contact the manufacturer
  • Consult your healthcare provider for interim guidance
  • Consider filing a complaint with relevant health authorities if needed

How to prevent similar issues

  • Verify labeling clearly marks a device as non-patient-use when used for demonstration
  • Implement a procedure to isolate demonstration devices from patient-use stock
  • Regularly review recall and safety notices from manufacturers and regulators

Documentation advice

Keep the recall notice, device labels, lot numbers, purchase records, and any correspondence with the manufacturer

Product Details

Two Emdogain demonstration devices are affected: Article Numbers 440.230V10 and 475.132V10. Lot numbers for 440.230V10 are EPZM8, HPT6, KEWN9, NAAM6, VAW80. Lot numbers for 475.132V10 are CRL56 and HPHJ1. A total of 61 units are involved. Distribution was nationwide in the United States, including AZ, CA, DE, FL, ID, MO, TN, TX, UT, and VA.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 61 units recalled
  • Article Numbers 440.230V10 and 475.132V10
  • Lot numbers EPZM8, HPT6, KEWN9, NAAM6, VAW80 (440.230V10) and CRL56, HPHJ1 (475.132V10)
  • Nationwide US distribution in AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA
  • Hazard: demonstration device could be placed in patients
  • Notification by letter

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
440.230V10
475.132V10
Affected States
ALL
Report Date
December 3, 2025
Recall Status
ACTIVE

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