Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LipiFlow Thermal Pulsation System/LipiFlow Recalled by Tearscience, Inc Due to Labeling: The labeled storage temperature is not consistent...
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 Tearscience, Inc directly.
Affected Products
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Quantity: 94,095 units.
Why Was This Recalled?
Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Tearscience, Inc
Tearscience, Inc has 2 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