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MY MASK-E
ESPANSIONE MARKETING SPA · Model MY MASK-E/PS · UDI-DI 08056389700378
IRT
Prescription
10
510(k) clearances
6,878
Adverse events (12 deaths)
24
Recalls
274
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-18 | Navajo Manufacturing Company | If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then t |
| 2024-02-08 | EYE COMFORT CARE LLC | 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 eleme |
| 2022-10-24 | Whele LLC DBA Perch | The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation. |
| 2022-10-24 | Whele LLC DBA Perch | The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation. |
| 2022-10-24 | Whele LLC DBA Perch | The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation. |
| 2016-09-15 | Battle Creek Equipment Co. | Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns. |
| 2016-04-15 | 2k Innovations Inc. | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. |
| 2016-04-15 | 2k Innovations Inc. | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. |
| 2016-04-15 | 2k Innovations Inc. | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. |
| 2016-04-15 | 2k Innovations Inc. | During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.