Nidek recalls

Nidek has 21 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 8 Jan 2020.

Total recalls21since 2013

Last 12 months0reported

Class I00% of total

Ongoing0latest 8 Jan 2020

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 19 90%Class III 2 10%

Why nidek is recalled

Product types

By year

202015%
2018210%
201715%
2016314%
2015629%
2014733%
201315%

All nidek recalls, newest first

21 total

Reported	Class	Recall	Company	Reason	Where
8 Jan 2020Device	CLASS III	Specular Microscope recalled by Nidek	Nidek	Other	Nationwide
26 Dec 2018Device	CLASS III	RT-5100 Refractor, a component of the Epic-5100 System recalled by Nidek	Nidek	Other	FL
18 Apr 2018Device	CLASS II	Auto REF/Keratometer Ark-1s recalled by Nidek	Nidek	Other	26 states
29 Mar 2017Device	CLASS II	Final Fit recalled by Nidek	Nidek	Device Malfunction	Nationwide
7 Sep 2016Device	CLASS II	Specular Microscope Cem recalled by Nidek	Nidek	Device Malfunction	18 states
24 Aug 2016Device	CLASS II	Optical Biometer Al-Scan recalled by Nidek	Nidek	Device Malfunction	Nationwide
30 Mar 2016Device	CLASS II	RT-5100 (Epic 5100) Refractor and RT 3100 Refractor recalled by Nidek	Nidek	Other	Nationwide
2 Sep 2015Device	CLASS II	OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic recalled	Nidek	Device Malfunction	Nationwide
22 Jul 2015Device	CLASS II	Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator recalled	Nidek	Other	14 states
22 Jul 2015Device	CLASS II	Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser recalled	Nidek	Other	14 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.