Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AUTO REF/KERATOMETER ARK-1s Recalled by Nidek Inc. Due to There is possibly a difference between the measured...

Date: December 20, 2017
Company: Nidek Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Nidek Inc. directly.

Affected Products

AUTO REF/KERATOMETER ARK-1s

Quantity: 63 untis

Why Was This Recalled?

There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s.

Where Was This Sold?

This product was distributed to 26 states: AL, AK, AR, CA, CO, DE, FL, GA, ID, IL, IN, MD, MI, MO, MT, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WV

Affected (26 states)Not affected

About Nidek Inc.

Nidek Inc. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report