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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Straumann
- Product type
- Demonstration dental device (Emdogain)
- Model numbers
- 440.230V10, 475.132V10
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 17, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Identify if you have Article Numbers 440.230V10 or 475.132V10
- Check for the listed lot numbers EPZM8, HPT6, KEWN9, NAAM6, VAW80 (440.230V10) or CRL56, HPHJ1 (475.132V10)
- 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
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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
- 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
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Safety Guide
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