Nidek Green Laser Photocoagulator Accessories Recalled for Missing Labels
Nidek Inc is recalling 22 units of GYC-1000 laser accessories because they are missing required Laser Aperture labels.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a missing label (documentation issue) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Nidek Inc is recalling 22 units of the Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system (Model GYC4DD-1). The recall is due to missing Laser Aperture labels on the accessories to the GYC-1000 laser.
The affected units were distributed in the United States to the states of California, Illinois, Minnesota, Missouri, Oregon, Utah, Rhode Island, Massachusetts, Washington, Nebraska, New York, New Jersey, Texas, and Wisconsin. The GYC-1000 system is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
Consumers and healthcare facilities should stop using the affected accessories and contact Nidek Inc for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Nidek Inc
- Hazard
- Affected units
- 22
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model GYC4DD-1
Distribution
Part of a larger recall action
This product is one of 2 recalled by Nidek Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Nidek Inc
See all →- LowNidek Specular Microscope Recalled for Electromagnetic Noise Exceeding Standards
FDA (Devices) · 2020-01-08
- LowNidek RT-5100 Refractor Recalled for Incomplete Lens Bonding
FDA (Devices) · 2018-12-26
- ModerateNidek ARK-1s Auto Ref/Keratometer Recalled for Measurement Discrepancy
FDA (Devices) · 2018-04-18
- HighNidek EC-5000 Excimer Laser Software Recall for Unintended Correction Programming
FDA (Devices) · 2017-03-29
- ModerateNidek Specular Microscope CEM-530 Software Recall for Unapproved Feature
FDA (Devices) · 2016-09-07
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
Similar recalls
- LowNidek GYC-1000 Green Laser Photocoagulator Recalled for Missing Aperture Label
FDA (Devices) · 2014-08-20
- ModerateNidek MC-500 Laser Photocoagulator Recalled for Missing Aperture Label
FDA (Devices) · 2014-08-06
- HighNidek MC-500 Laser Photocoagulator Recalled for Power Output Failure
FDA (Devices) · 2014-11-26
- ModerateNidek MC-500 Laser Photocoagulator Recalled for Unreported Engineering Change
FDA (Devices) · 2014-11-26
- HighNidek MC-500 Laser Photocoagulator Recalled for Spot Size Control Defect
FDA (Devices) · 2015-02-25
- ModerateNidek YC-1800 Ophthalmic YAG Laser System Recalled for Pitting Lens
FDA (Devices) · 2015-04-08