The Recall Desk
HighFDA (Devices)·Z-2586-2024·Announced 2024-08-21

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.

What this means for you

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
Hazard
  • wire-detachment
  • electrical-short
  • burn-injury

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

Distributed nationwide across the United States.