Straumann recalls Emdogain (article numbers 440.230V10 and 475.132V10) due to risk of being used on patients instead of for demonstration purposes only.
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Straumann is recalling Emdogain products with specific article numbers because they are intended for demonstration only and could be mistakenly used on patients. This poses a serious risk of harm if the product is used incorrectly in medical procedures.
The product is designed only for demonstration purposes, not for patient use. If mistakenly used on patients during medical procedures, it could cause injury or harm due to its intended medical application.
Patients who might have received the recalled Emdogain products for medical procedures are at risk. Healthcare providers using the product for demonstrations could also be affected.
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.
Immediately stop using the recalled Emdogain products if they were intended for patient procedures.
No, this product is intended only for demonstration purposes and not for patient use.
Stop using it immediately and contact Straumann USA LLC for further instructions.
Look for article numbers 440.230V10 or 475.132V10 with specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Straumann to request your refund or repair — edit it as you like.
Subject: Recall Z-0582-2026 — Straumann Straumann Hello, I own a Straumann that is covered by recall Z-0582-2026 from Straumann. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
