Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 26, 2016
LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.
Tearscience, Inc recalled LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 … - a moderate-severity action.
LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 … was recalled by Tearscience, Inc in October 26, 2016. Reason: Complaints related to an error condition occurring during patient treatment where the FipiFlow System automat…. Check the official notice for the remedy. Verify recall #Z-0093-2017 with the FDA Devices before acting.
The recall
Tearscience, Inc issued this moderate-severity FDA Devices recall-Complaints related to an error condition occurring during patient treatment where the FipiFlow System automat….
- Moderate
- severity level
- Class II
- classification
- October 26, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0093-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0093-2017) was formally reported on October 26, 2016, with the manufacturer initiating the action on September 13, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Tearscience, Inc is listed as the recalling firm, operating out of Morrisville, NC. Federal records list the affected scope as 1,200 Activators (120 boxes of 10 units).
The documented reason for this recall is: Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator. Distribution data in the federal record shows the product reached: US Distribution including states of: AK, AR, CA, CO, FL, GA, ID, IL, IN, LA, MD, MA, MN, MO, NV, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA , WA, WI and Puerto Rico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1,200 Activators (120 boxes of 10 units)
Related Recalls
6
3 from same agency
Product description
LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
Reason for recall
Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0093-2017 |
| Date reported | October 26, 2016 |
| Date initiated | September 13, 2016 |
| Recalling firm | Tearscience, Inc |
| Firm location | Morrisville, NC |
| Affected scope | 1,200 Activators (120 boxes of 10 units) |
| Distribution | US Distribution including states of: AK, AR, CA, CO, FL, GA, ID, IL, IN, LA, MD, MA, MN, MO, NV, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA , WA, WI and Puerto Rico. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0093-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
LipiFlow thermal Pulsation System, consisting of Console and Activator, Model LFD-1100 The LipiFlow Thermal Pulsation System is intended for use by physicians as a prescription device for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.. Recalled by Tearscience, Inc. Units affected: 1,200 Activators (120 boxes of 10 units).
Why was this product recalled? ▼
Complaints related to an error condition occurring during patient treatment where the FipiFlow System automatically stopped treatment after detecting a problem with the Activator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 26, 2016. Severity: Moderate. Recall number: Z-0093-2017.
Where was the recalled product distributed? ▼
Distribution: US Distribution including states of: AK, AR, CA, CO, FL, GA, ID, IL, IN, LA, MD, MA, MN, MO, NV, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA , WA, WI and Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0093-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 26, 2016. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.