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.
What this means for you
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 →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02