FDA Device recall Z-1535-2017
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
- FDA Device
- Class II
- terminated
- Published 2017-03-29
On 2017-03-29 the FDA classified a Class II recall of LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile by Tearscience, citing labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1535-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-30 |
| Published | 2017-03-29 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tearscience |
| Distribution | US |
Product
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Reason
Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
Identifiers
| code_info | Model number LFD-1000 and LFD-1100, All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1535-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.