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Sunbeam

Jarden Consumer Solutions · Model 027045804875 · UDI-DI 00027045804875

IRT
10
510(k) clearances
6,878
Adverse events (12 deaths)
24
Recalls
274
Facilities

Description

Heating Pad

Recalls

DateFirmReason
2026-02-18Navajo Manufacturing CompanyIf 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
2024-02-08EYE COMFORT CARE LLCDue 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
2022-10-24Whele LLC DBA PerchThe products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.
2022-10-24Whele LLC DBA PerchThe products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.
2022-10-24Whele LLC DBA PerchThe products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.
2016-09-15Battle Creek Equipment Co.Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns.
2016-04-152k Innovations Inc.During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
2016-04-152k Innovations Inc.During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
2016-04-152k Innovations Inc.During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.
2016-04-152k 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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Data 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.