Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LipiFlow thermal Pulsation System Recalled by Tearscience, Inc Due to Complaints related to an error condition occurring during...
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, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
Quantity: 1,200 Activators (120 boxes of 10 units)
Why Was This Recalled?
Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.
Where Was This Sold?
This product was distributed to 28 states: AK, AR, CA, CO, FL, GA, ID, IL, IN, LA, MD, MA, MN, MO, NV, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI
About Tearscience, Inc
Tearscience, Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report