Boston Scientific SC-4318 Clik X Anchor Recall: Sterile Anchor Lack of Sterility Assurance
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.
Recall notice
Sterile anchors my lack sterility assurance.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/49323-boston-scientific-sc-4318-clik-x-anchor-recall-sterile-anchor.
Source Summary by GovInfoNow · govinfonow.com/recall/49323-boston-scientific-sc-4318-clik-x-anchor-recall-sterile-anchor · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2404-2026
Cite this page
“Boston Scientific SC-4318 Clik X Anchor Recall: Sterile Anchor Lack of Sterility Assurance.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49323-boston-scientific-sc-4318-clik-x-anchor-recall-sterile-anchor. Based on FDA recall #Z-2404-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2404-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check for the model SC-4318, Clik X Anchor with reference number M365SC43180. The lot number 35107836 is also associated with this recall.
- Brand
Boston Scientific- Product
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180- Category
Medical device
What to do — step by step
Contact Boston Scientific
Reach out to Boston Scientific for specific instructions on how to handle the recalled device.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
FDA distribution: “US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Louisiana, Maryland, Oklahoma, South Carolina, Utah.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-2404-2026 (April 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2404-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.