Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The Recalled by Nidek Inc Due to Nidek Inc. received information from our manufacturer NIDEK...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nidek Inc directly.
Affected Products
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.
Quantity: 17
Why Was This Recalled?
Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nidek Inc
Nidek Inc has 18 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report