Z-1535-2017Class II

LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile

Name: Z-1535-2017 LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Creator: Tearscience, Inc
Published: 2017-01-30
License: https://open.fda.gov/license/

TearScience, Inc. / initiated 2017-01-30 / Terminated / root cause: labeling and UDI

FDA source

Tearscience, Inc began a recall of LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile on 2017-01-30. FDA classified it as Class II and gives the reason as "Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1535-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-30
Posted: 2017-03-22
Terminated: 2017-11-27
Recalling firm: TearScience, Inc.
Product: LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Product code: ORZ Eyelid Thermal Pulsation System
Reason for recall: Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Tearscience sent an MEDICAL DEVICE LABELING CORRECTION/RECALL letter dated January 30, 2017. .Actions to be Taken by Customer: Within 10 business days of receipt of this letter, please take the following actions: 1) Read the enclosed Summary of Important Labeling Changes for the LipiFlow System. 2) Complete the Acknowledgement and Receipt form at www.TSVerify.pmcprograms.com or return the enclosed completed form by email or mail. 3) If you have stored Activators in an environment that is not temperature controlled (without heat and air conditioning), discontinue use of these Activators and call TearScience Labeling Change Hotline at (844) 872-5658. For any questions regarding this letter, please call (844) 872-5658 Monday through Friday, 8:00AM to 6:00PM, Eastern Time. We want to thank you for being a valuable TearScience partner, and as always would like to thank you for your business, your trust, and your commitment to treating MGD. For further questions please call (919) 459-4831.
Quantity in commerce: 94,095 units.
Distribution: US (nationwide)
Product codes and lots: Model number LFD-1000 and LFD-1100, All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1535-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1535-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-22

Product code ORZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)