CryoLife recalls BioGlue surgical adhesive model BG3510-5-G for EU distribution. Product not approved for EU use and should not have been sold there.
Product is not approved for use in the EU and should not have been distributed in the EU.
CryoLife is recalling BioGlue surgical adhesive model BG3510-5-G because it was distributed in the EU without proper approval. This product should not have been sold in the European Union.
The product was not approved for use in the EU, meaning it may not meet safety standards there. This could lead to improper medical use or complications if used without regulatory approval.
People who purchased or used BioGlue surgical adhesive model BG3510-5-G in the EU. Those who received the product through medical channels are most at risk.
Check for the model number BG3510-5-G on the product packaging. The product was distributed in the EU with lot number BG000255.
Look for model number BG3510-5-G and lot number BG000255 on the product packaging.
No, the product was not approved for EU use and should not have been distributed there.
The official recall record does not specify a remedy, so check with CryoLife for guidance.
The recall states the product was not approved for EU use, but no specific injury risk is mentioned.
We’ve drafted a message you can send CryoLife to request your refund or repair — edit it as you like.
Subject: Recall Z-0384-2022 — CryoLife CryoLife Hello, I own a CryoLife that is covered by recall Z-0384-2022 from CryoLife. 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.
