# FDA recall Z-1348-2018

> **Nidek Inc.** · Class II · device recall initiated 2017-12-20.

## 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.

## Distribution

Distributed domestically to 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.

## Key facts

- **Recall number:** Z-1348-2018
- **Recalling firm:** Nidek Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-20
- **Report date:** 2018-04-18
- **Termination date:** 2019-03-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fremont, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1348-2018

## Citation

> AI Analytics. FDA recall Z-1348-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1348-2018. Source: US FDA. Licensed CC0.

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