Exact FDA event identifier

Event 76365

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: January 30, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Tearscience, Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1535-2017

Recall number: Z-1535-2017
Initiated: January 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Tearscience, Inc
Quantity: 94,095 units.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

US (nationwide)