AUTO REF/KERATOMETER ARK-1s — Class II medical device recall Z-1348-2018
Terminated recall by Nidek Inc., reported 2018-04-18, distributed in AK, AL, AR, CA, CO, DE, FL, GA…. There is possibly a difference between the measured dioptric value of the subjective measurement mode and the
| Recall number | Z-1348-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nidek Inc., Fremont, CA, United States |
| Recall initiated | 2017-12-20 |
| Classified | 2018-04-10 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2019-03-18 |
| Distributed | AK, AL, AR, CA, CO, DE, FL, GA, ID, IL, IN, MD, MI, MO, MT, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WV |
| Quantity | 63 untis |
| Serial numbers | 620337, 620340, 620341, 620343, 620345, 620349, 620350, 620355, 620356, 620359, 620363, 620370, 620371, 620374, 620376, 620377, 620380, 620381, 620384, 620387, 620389, 620391, 620394, 620398, 620400 and 38 more |
| Model numbers | ARK-1S |
Product
AUTO REF/KERATOMETER ARK-1s
Reason for recall
There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.
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-1348-2018. 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.