Z-2586-2024Class II

Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22...

Name: Z-2586-2024 Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22...
Creator: Eye Comfort Care Llc
Published: 2024-02-08
License: https://open.fda.gov/license/

Eye Comfort Care LLC / initiated 2024-02-08 / Completed / root cause: supplier

FDA source

EYE COMFORT CARE LLC began a recall of Brand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24 Serial # ag22 Product Description: Heated eye mask Component: Heating... on 2024-02-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2586-2024
Classification: Class II
Status: Completed
Initiated: 2024-02-08
Posted: 2024-08-14
Recalling firm: Eye Comfort Care LLC
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
Product code: IRT Pad, Heating, Powered
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.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: Between 02/08/2024 to 05/18/2024, the firm send via email, a Stop Sale Notice and an "Voluntary Product Recall Notice" for it UNCLOG Heated Eye Masks (Lot Model# AG23JN24) inform customers that an unauthorized material substitution was made in the manufacturing process of these masks. Additionally, it was identified that a smaller safety clip was used and could compromise the integrity of the mask. Customers are instructed to: 1. Cease Use Immediately. Stop using the UNCLOG Heated Eye Mask to avoid any potential risks. 2. Claim a replacement. The firm is committed to replacing their current masks with a new, fully tested new UNCLOG eye mask at no additional cost. Any questions or assistance, contact Vivian Surya, Founder/CEO of Eye Comfort Care LLC at 888-781-2811 or email at [email protected]
Quantity in commerce: 500
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.
Product codes and lots: Lot Code: AG23JW24 Serial # ag22

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2586-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2586-2024	Class II	Completed	Voluntary: Firm initiated	2024-08-21	2024-08-14

Product code IRT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)