Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Sonogage EyeScan Recalled by Sonogage Inc Due to During an FDA inspection on 7/15-26/2013, it was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sonogage Inc directly.
Affected Products
Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
Quantity: 564 units
Why Was This Recalled?
During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sonogage Inc
Sonogage Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report