PlainRecalls

Nidek, Inc.

Compiled from official public sources by the publisher.

21 recalls on record · Latest: Jan 8, 2020

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Agency notice ledger

Federal filing book Nidek, Inc. MID-BOOK · SINGLE-AGENCY

#781 of 14,151 · 21 notices · 0.020% archive

  • BOOK 21 notices
  • RANK #781 of 14,151
  • SHARE 0.020% archive
  • AGENCY FDA Devices (21)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jan 8, 2020
  • PHOTO A&h Focal Inc.

Nearest notice-volume peer: A&h Focal Inc. (0 notice gap)

Nidek, Inc. accounts for about 0.020% of the 104,423-notice archive on 21 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Nidek, Inc. sits among 14,151 recalling firms

Nidek, Inc. ranks 781st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Nidek, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

21 781st of 14151 higher than 13,362 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Nidek, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Nidek, Inc. holds about 0.020% of archive notices alongside 21 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Low Jan 8, 2020

NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.
FDA Devices Low Dec 26, 2018

RT-5100 Refractor, a component of the Epic-5100 System.
FDA Devices Moderate Apr 18, 2018

AUTO REF/KERATOMETER ARK-1s
FDA Devices Moderate Mar 29, 2017

Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
FDA Devices Moderate Sep 7, 2016

SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal obse
FDA Devices Moderate Aug 24, 2016

OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.
FDA Devices Moderate Mar 30, 2016

RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.
FDA Devices Moderate Sep 2, 2015

OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis.
FDA Devices Moderate Jul 22, 2015

Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Devices Moderate Jul 22, 2015

Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Devices Moderate Jun 10, 2015

EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Opthalmic: NIDEK EXCIMER LASER CORNEAL SURGERY SYSTEM, model EC-5000, is an ophthalmic laser system used for correction of corneal refraction and ablation of the corneal surface.
FDA Devices Moderate Apr 8, 2015

YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by mechanical disruption caused by energy of the YAG laser pulses.
FDA Devices Moderate Feb 25, 2015

MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
FDA Devices Moderate Nov 26, 2014

Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.
FDA Devices Moderate Nov 26, 2014

MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used for retinal photocoagulation for treatment of ocular fundus diseases.
FDA Devices Moderate Nov 26, 2014

Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The system is composed as a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
FDA Devices Moderate Aug 20, 2014

GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
FDA Devices Moderate Aug 6, 2014

MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
FDA Devices Moderate Jul 9, 2014

Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.
FDA Devices Moderate Jul 2, 2014

RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions.
FDA Devices Moderate Sep 4, 2013

NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.

Nidek, Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (21 here).

A&h Focal Inc. 21 Able Groupe Inc 21 Alvogen, Inc 21 Aroa Biosurgery, LTD. 21 Aston Martin 21

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Aroa Biosurgery, LTD. 21 Corin Ltd 21 Covidien 21 Custom Medical Specialties, Inc. 21

Frequently Asked Questions

How many federal recall notices name Nidek, Inc.? ▼
PlainRecalls indexes 21 distinct federal recall events naming Nidek, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Nidek, Inc. sit among other recalling firms? ▼
Nidek, Inc. ranks #781 of 14,151 by distinct recall-event count among 14,151 firms in this archive (94th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Nidek, Inc.'s notices? ▼
FDA Devices accounts for 21 of this firm's 21 indexed notices.
What product category dominates Nidek, Inc.'s filing book? ▼
Filings for Nidek, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Nidek, Inc.: 21 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Nidek, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026