Nidek GYC-1000 Green Laser Photocoagulator Recalled for Missing Aperture Label
Nidek Inc is recalling 567 GYC-1000 Green Laser Photocoagulator systems because the required laser aperture label was not applied to the devices.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a missing label, which is a documentation and packaging issue. No injuries, illnesses, or functional defects are reported in the source text.
Plain-English summary
Nidek Inc is recalling 567 units of the GYC-1000 Green Laser Photocoagulator system. The recall was initiated because the laser aperture label was not applied to certain devices in the field as required by FDA regulations.
The GYC-1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy, and trabeculoplasty. The affected devices were distributed nationwide in the United States. Specific serial numbers for the affected units are listed in the official recall record.
Healthcare facilities and users of these devices should stop using the affected units and contact Nidek Inc for further instructions regarding the recall and corrective actions.
The recalled product
- Product
- 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.
- Manufacturer
- Nidek Inc
- Hazard
- Affected units
- 567
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: GYC-1000
Distribution
Distributed nationwide across the United States.
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
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 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
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateNidek Green Laser Photocoagulator Accessories Recalled for Missing Labels
FDA (Devices) · 2015-07-22
- ModerateNidek GYC-1000 Laser Accessories Recalled for Missing Labels
FDA (Devices) · 2015-07-22
- 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
- ModerateNidek YC-1800 Ophthalmic YAG Laser System Recalled for Pitting Lens
FDA (Devices) · 2015-04-08