Nidek Inc.: Medical Device Recall in 2018 - (Recall #: Z-1348-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

AUTO REF/KERATOMETER ARK-1s

Product Classification:

Class II

Date Initiated: December 20, 2017

Date Posted: April 18, 2018

Recall Number: Z-1348-2018

Event ID: 79553

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.

Status: Terminated

Product Quantity: 63 untis

Code Information:

Model No. ARK-1s, Serial No. 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, 620403, 620404, 620407, 620410, 620412, 620415, 620417, 620418, 620420, 620422, 620425, 620427, 620429, 620433, 620435, 620437, 620440, 620444, 620445, 620447, 620450, 620452, 620454, 620455, 620459, 620462, 620464, 620466, 620469, 620471, 620474, 620477, 620478, 620480, 620482, 620485, 620487, 620489.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated