Data Foundry

Medical device recalls 2024

Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask… — Class II medical device recall Z-2586-2024

Completed recall by EYE COMFORT CARE LLC, reported 2024-08-21, distributed nationwide. Due to a change in the safety clips for the heated eye masks, the wires to the safety clips may detach as a re

Recall numberZ-2586-2024
Product typeMedical device
ClassificationClass II
StatusCompleted
Voluntary or mandatedVoluntary
Recalling firmEYE COMFORT CARE LLC, Gales Creek, OR, United States
Recall initiated2024-02-08
Classified2024-08-14
Reported by FDA2024-08-21
DistributedNationwide (US)
Quantity500
Reason classesdevice malfunction
Lot numbersAG23JW24
Serial numbersAG22
Model numbersAG23JW24

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2586-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.