FDA-Device2026-06-17Class IIPACKAGING DEFECT
Boston Scientific Clik X Anchor recalled for sterility assurance concerns
What this means
Boston Scientific is recalling the Model SC-4318 Clik X Anchor (Lot #35107836) because sterile anchors may lack proper sterility assurance. Approximately 43 units were distributed across six U.S. states.
- If you received this product, contact Boston Scientific for instructions on return or replacement.
- Do not use the affected anchors if you have not already implanted them.
The agency's original wording
Hazard
Sterile anchors my lack sterility assurance.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK.
Affected count
43 units
Manufactured in
25155 Rye Canyon Loop, N/A, Valencia, CA, United States
Products
Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2404-2026Want us to check the next one for you?
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