International Life Sciences recalls Artelon FlexBand Dynamic Matrix (Ref: 310: 00850003396019) due to failed bacterial endotoxin testing. Consumers should check product details to determine if affected.
Augmentation devices failed bacterial endotoxin testing.
International Life Sciences is recalling Artelon FlexBand Dynamic Matrix devices because they failed bacterial endotoxin testing. This could pose a risk of infection or health issues if used without proper sterilization.
The devices failed bacterial endotoxin testing, meaning they may contain harmful bacteria or toxins that could cause infections if used improperly. This is a quality control issue that could lead to health risks if the product is not properly sterilized.
Users of Artelon FlexBand Dynamic Matrix devices with the reference number 31057 are affected. Those using the product for medical purposes are at higher risk due to potential infection.
Check for the product reference number 31057 on the Artelon FlexBand Dynamic Matrix device. The GTIN number is 00850003396019.
Look for the reference number 31057 or GTIN 00850003396019 on the device to confirm if it is affected.
The Artelon FlexBand Dynamic Matrix devices failed bacterial endotoxin testing, which could pose a risk of infection if used without proper sterilization.
Check for the reference number 31057 or GTIN 00850003396019 on the device.
The recall does not specify a remedy, so check with International Life Sciences for further instructions.
We’ve drafted a message you can send International Life Sciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1554-2026 — International Life Sciences International Life Sciences Hello, I own a International Life Sciences that is covered by recall Z-1554-2026 from International Life Sciences. 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.