Canon Full Auto Ref-Keratometer RK-F2 — Class II medical device recall Z-1404-2013
Terminated recall by Canon Inc., reported 2013-06-05, distributed nationwide. Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measu
| Recall number | Z-1404-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canon Inc., Tokyo, N/A, Japan |
| Recall initiated | 2012-12-05 |
| Classified | 2013-05-25 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2013-09-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, GB, JP, KR, SG |
| Quantity | 384 units |
| Model numbers | 6937B002AA |
Product
Canon Full Auto Ref-Keratometer RK-F2, Catalog Number 6937B002AA. Product Usage: This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
Reason for recall
Canon Inc. had received 17 claims from our foreign sales companies between October to November 2012 that measurement value of RK-F2s refractive power (SPH value) sometimes indicated abnormal value which occurs approximately 5% in probability.
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-1404-2013. 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.