Boston Scientific recalls SC-4318 Clik X Anchor due to sterile anchors lacking sterility assurance. Affected units have specific model and lot numbers. Consumers should contact the company for details.
Sterile anchors my lack sterility assurance.
Boston Scientific is recalling its SC-4318 Clik X Anchor because the sterile anchors lack proper sterility assurance. This could lead to infections or other health risks if used in medical procedures.
The sterile anchors in this device do not have adequate sterility assurance, meaning they might not be clean enough for medical use. This could lead to infections or other complications during surgical procedures.
Medical professionals using the SC-4318 Clik X Anchor for procedures are most at risk. Patients receiving the device during surgery may also be affected.
Check for the model SC-4318, Clik X Anchor with reference number M365SC43180. The lot number 35107836 is also associated with this recall.
Reach out to Boston Scientific for specific instructions on how to handle the recalled device.
The sterile anchors lack sufficient sterility assurance, which could lead to infections during medical procedures.
Contact Boston Scientific directly for specific instructions on handling the recalled device.
The recall indicates a potential infection risk, but the record does not specify if serious injury can occur.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2404-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2404-2026 from Boston Scientific. 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.