Tearscience, Inc: Medical Device Recall in 2017 - (Recall #: Z-1535-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 30, 2017

Date Posted: March 29, 2017

Recall Number: Z-1535-2017

Event ID: 76365

Reason for Recall:

Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.

Status: Terminated

Product Quantity: 94,095 units.

Code Information:

Model number LFD-1000 and LFD-1100, All lots

Distribution Pattern:

US (nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated