Tearscience LipiFlow System Recalled for Inconsistent Storage Temperature Labeling
Tearscience is recalling LipiFlow Thermal Pulsation Systems because the labeled storage temperature does not match tested conditions for the full shelf life.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding storage temperatures. No illnesses or injuries are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Tearscience, Inc. is recalling the LipiFlow Thermal Pulsation System and LipiFlow System Activator (Disposable). The recall involves 94,095 units of the device, which is prescription-only and sterile. The affected products include model numbers LFD-1000 and LFD-1100 across all lots. The devices were distributed nationwide in the United States.
The recall was initiated due to a labeling issue. The labeled storage temperature for the devices is not consistent with the temperature conditions that were tested for the entire four-year shelf life duration. This discrepancy may affect the reliability of the storage instructions provided to users.
Healthcare providers and patients who have these devices should contact Tearscience, Inc. for further instructions on how to proceed. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
- Manufacturer
- Tearscience, Inc
- Hazard
- Affected units
- 94,095
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model number LFD-1000 and LFD-1100
- All lots
Distribution
Distributed nationwide across the United States.
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