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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94929

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 08, 2024
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
EYE COMFORT CARE LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2586-2024
Recall number
Z-2586-2024
Initiated
February 08, 2024
Classification
Class II
Status
Completed
Recalling firm
EYE COMFORT CARE LLC
Quantity
500

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Vendor change control

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Inspect official wording and provenance

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.

Code information

Lot Code: AG23JW24 Serial # ag22

Distribution pattern

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.