LipiFlow Thermal Pulsation System/LipiFlow — Class II medical device recall Z-1535-2017
Terminated recall by Tearscience, Inc, reported 2017-03-29, distributed nationwide. Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the ent
| Recall number | Z-1535-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tearscience, Inc, Morrisville, NC, United States |
| Recall initiated | 2017-01-30 |
| Classified | 2017-03-22 |
| Reported by FDA | 2017-03-29 |
| Terminated | 2017-11-27 |
| Distributed | Nationwide (US) |
| Quantity | 94,095 units |
| Reason classes | labeling |
| Model numbers | LFD-1000, LFD-1100 |
Product
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Reason for recall
Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1535-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.