Heated Eye Mask Recalled Due to Detachable Wires and Burn Risk
EYE COMFORT CARE LLC is recalling the UNclog Eye Mask due to safety clips that may allow wires to detach, potentially causing electrical shorts and burn injuries.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a risk-of-harm product where burn injury is plausible but has not yet been reported. Per the rubric, theoretical hazards without reported illnesses warrant a score of 3.
Plain-English summary
EYE COMFORT CARE LLC is recalling the UNclog Eye Mask, model AG23JW24 (serial # ag22), a heated eye mask device. The recall affects approximately 500 units distributed nationwide.
The recall was initiated due to a change in the design of the safety clips on the heating unit. The wires connected to the safety clips may detach when the mask is pulled or tugged. If the wires detach, they could cause a short circuit in the heating element and potentially result in burn injuries to the user.
The affected masks were distributed in 23 states: Alabama, Arizona, California, Connecticut, Florida, Kansas, Kentucky, Massachusetts, Maine, Montana, North Carolina, North Dakota, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, and Wisconsin.
The recalled product
- Product
- Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating unit, wire
- Manufacturer
- EYE COMFORT CARE LLC
- Affected units
- 500
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 (1)
- Lot Code: AG23JW24 Serial # ag22
Distribution
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