FDA Medical Device Recalls (openFDA)
EYE COMFORT CARE LLC: 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
- Recall number
- Z-2586-2024
- 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
- Status
- Completed
- Initiated
- 2024-02-08
- Posted
- 2024-08-14
- Terminated
- not on file
- Reason
- 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
- 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 vivian@eyeconfortcare.com
- Quantity
- 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.
- Lot, serial or model codes
- Lot Code: AG23JW24 Serial # ag22
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IRT
- Firm FEI
- 3017065824
- Firm city
- Gales Creek
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28