🔍 RecallPedia

Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.

Class I - Dangerous
🏥 Medical Devices Recalled: August 9, 2013 Sonogage Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial #: ES10001 - ES10002, ES10004 -ES10012, ES10014 - ES10040, ES10042 - ES100167, ES10170-ES10185, ES10187 - ES10214, ES10218 - ES10224, ES10226, ES10228 - ES10230, ES10233, ES10235-ES10242, ES10244 - ES10252, ES1024-ES10426, ES10253 - ES10260, ES10262, ES10267 - ES10277, ES10279 - ES10306, ES10308 - ES10347, ES10349-ES10357, ES10359 - ES10423, ES10427 - ES10444, ES10446 - ES10472, ES10474, ES10476 - ES10478, ES10481 - ES10483, ES10485 - ES10508, ES10510, ES10512 - ES10529, ES10531 - ES10543, ES10545 - ES10546, ES10548 - ES10558, ES10560 - ES10566, ES10568 - ES10570, ES1059, T10217 & T80002-T80020.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Sonogage Inc
Reason for Recall:
During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clearance for the device.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.

Product Codes/Lot Numbers:

Serial #: ES10001 - ES10002, ES10004 -ES10012, ES10014 - ES10040, ES10042 - ES100167, ES10170-ES10185, ES10187 - ES10214, ES10218 - ES10224, ES10226, ES10228 - ES10230, ES10233, ES10235-ES10242, ES10244 - ES10252, ES1024-ES10426, ES10253 - ES10260, ES10262, ES10267 - ES10277, ES10279 - ES10306, ES10308 - ES10347, ES10349-ES10357, ES10359 - ES10423, ES10427 - ES10444, ES10446 - ES10472, ES10474, ES10476 - ES10478, ES10481 - ES10483, ES10485 - ES10508, ES10510, ES10512 - ES10529, ES10531 - ES10543, ES10545 - ES10546, ES10548 - ES10558, ES10560 - ES10566, ES10568 - ES10570, ES1059, T10217 & T80002-T80020.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2202-2013