Boston Scientific Clik X Anchor recalled for sterility assurance concerns
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.
From the FDA notice · Read the official notice ↗ · All Boston Scientific recalls
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 43 units
- Illnesses reported
- None reported
- Manufactured in
- 25155 Rye Canyon Loop, N/A, Valencia, CA, United States
- Classification
- Class II
- Recall number
- Z-2404-2026
In the FDA's words
- Description
- Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180 Sterile anchors my lack sterility assurance. GTIN: 08714729905318/Lot # 35107836 Distribution: US Nationwide distribution in the states of MD, UT, FL, LA, SC, OK. Affected quantity: 43 units
- Hazard
- Sterile anchors my lack sterility assurance.
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ModerateFDAOct 29, 2026