LipiFlow thermal Pulsation System — Class II medical device recall Z-0093-2017
Terminated recall by Tearscience, Inc, reported 2016-10-26, distributed in AK, AR, CA, CO, FL, GA, ID, IL…. Complaints related to an error condition occurring during patient treatment where the FipiFlow System automati
| Recall number | Z-0093-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tearscience, Inc, Morrisville, NC, United States |
| Recall initiated | 2016-09-13 |
| Classified | 2016-10-17 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2017-02-09 |
| Distributed | AK, AR, CA, CO, FL, GA, ID, IL, IN, LA, MA, MD, MN, MO, NC, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, VA, WA, WI |
| Lot numbers | 201615220020 |
| Model numbers | LFD-1100 |
Product
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.
Reason for recall
Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.