CLASS II Device recall · Reported 21 Aug 2024 · FDA Enforcement Report
UNclog Eye Mask recalled by Eye Comfort Care
Eye Comfort Care is recalling UNclog Eye Mask, distributed nationwide in the US. The recall was initiated on 8 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2586-2024
- FDA event ID
- 94929
- Recalling firm
- Eye Comfort Care, Gales Creek, OR
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 8 Feb 2024
- FDA classified
- 14 Aug 2024
- Reported
- 21 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 8 Feb 2024 | Recall initiated by company | |
| 14 Aug 2024 | Classified by FDA | +188 days |
| 21 Aug 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaConnecticutFloridaKansasKentuckyMassachusettsMaineMontanaNorth CarolinaNorth DakotaNew JerseyNew MexicoNew YorkOhioOregonPennsylvaniaSouth CarolinaTexas
Questions about this recall
Is UNclog Eye Mask recalled?
Yes. Eye Comfort Care recalled UNclog Eye Mask on 8 Feb 2024. The recall is Class II and its status is Completed. Recall number Z-2586-2024.
Why was it recalled?
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.
Which lots are affected?
Lot Code: AG23JW24 Serial # ag22
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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