FDA recall Z-2586-2024

EYE COMFORT CARE LLC · Class II · device

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

Reason for recall

Due to a change in the safety clips for the heated eye masks, the wires to the safety clips may detach as a result of tugging and pulling and may cause a short in the heating element of the mask and could potentially cause burn injuries.

Distribution

U.S. Nationwide distribution in the states of AL, AZ, CA, CT, FL, KS, KY, MA, ME, MT, NC, ND, NJ, NM, NY, OH, OR, PA, SC, TX, VA, WA, and WI.

Key facts

Status
Completed
Initiation date
2024-02-08
Report date
2024-08-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gales Creek, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2586-2024