Stop using nowMedical device recall · FDA · Published October 17, 2025
Straumann Emdogain recall: Product intended for demo only placed in patients
Straumann recalls Emdogain (article numbers 440.230V10 and 475.132V10) due to risk of being used on patients instead of for demonstration purposes only.
“Straumann Emdogain recall: Product intended for demo only placed in patients.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51047-straumann-emdogain-recall-product-intended-for-demo-only-placed-in. Based on FDA recall #Z-0582-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0582-2026%22&limit=1).
The FDA announced on Oct. 17, 2025, that Straumann USA LLC is recalling Emdogain products because demonstration-only items may be placed in patients. The recall involves 61 units distributed nationwide.
How to tell if you have it
Brand: Straumann
Product: Emdogain
Article Numbers: 440.230V10, 475.132V10
Lot Numbers (Art. 440.230V10): EPZM8, HPT6, KEWN9, NAAM6, VAW80
Lot Numbers (Art. 475.132V10): CRL56, HPHJ1
The hazard
According to the FDA, the hazard is the possibility for this product, which is intended for demonstration purposes only, to be placed in patients.
Context
GovInfoNow's records show Straumann USA LLC has 13 other recalls on record since May 27, 2021. Recent brand recalls include a GM Helix Implant recall on Aug. 12, 2026, regarding packaging versus actual dimensions mismatch, and a Bone Level Tapered Implant recall on July 16, 2026, for potential wrong length implants. Other recent recalls of similar products include the Encore Medical EMPOWR Acetabular System Recall (Jan. 5, 2026), the Covidien Shiley Disposable Decannulation Plug Recall (April 23, 2026), and the Medical Action Industries Epidural Kits Recall (July 23, 2026).
How to tell if you have this one
Check for article numbers 440.230V10 or 475.132V10 on the product. The lot numbers for these items are EPZM8, HPT6, KEWN9, NAAM6, VAW80 for the first article and CRL56, HPHJ1 for the second.
Brand
Straumann
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Now
Immediately stop using the recalled Emdogain products if they were intended for patient procedures.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Delaware, Florida, Idaho, Missouri, Tennessee, Texas, Utah, Virginia.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0582-2026 (October 17, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0582-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.