Sonogage EyeScan — Class II medical device recall Z-2202-2013
Terminated recall by Sonogage Inc, reported 2013-09-25, distributed nationwide. During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and 510(k) clear
| Recall number | Z-2202-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sonogage Inc, Cleveland, OH, United States |
| Recall initiated | 2013-08-09 |
| Classified | 2013-09-16 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2015-09-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 564 units |
| Serial numbers | ES10001, ES10002, ES10004, ES10012, ES10014, ES100167, ES10040, ES10042, ES10170-ES10185, ES10187, ES10214, ES10218, ES10224, ES10226, ES10228, ES10230, ES10233, ES10235-ES10242, ES1024-ES10426, ES10244, ES10252, ES10253, ES10260, ES10262, ES10267 and 35 more |
Product
Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagnostic device for measurement of axial eye length.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2202-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.