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U.S. Department of Health and Human Services

Class 1 Device Recall Mighty Bliss Electric Heating Pad

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  Class 1 Device Recall Mighty Bliss Electric Heating Pad see related information
Date Initiated by Firm October 24, 2022
Date Posted November 23, 2022
Recall Status1 Open3, Classified
Recall Number Z-0238-2023
Recall Event ID 90977
Product Classification Pad, heating, powered - Product Code IRT
Product Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating
Pad, PE-MtyBls-HeatPad-12x24-Gry-V2
Code Information No UDI Lots: 220103
Recalling Firm/
Manufacturer		 Whele LLC DBA Perch
222 Berkeley St Fl 8
Boston MA 02116-3748
For Additional Information Contact Sedgwick Claims Management Services
866-918-8768
Manufacturer Reason
for Recall		 The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.
FDA Determined
Cause 2		 Device Design
Action On October 24, 2022, the firm notified retailers Amazon.com and Walmart of the recall. These internet retailers were instructed to notify users of the product about the recall using their customer information. Whele LLC will also have a website for the public that will include instructions for the recall as well as customer support for the recall. The website can be found at https://www.mightyblissheatingpadrecall.expertinquiry.com/ Users are asked to immediately cease use of the product and safely destroy the product by cutting the cord (after ensuring the product is unplugged.) Users are asked to take a photo of the destroyed product and upload it to the firm's recall website to verify that the product can no longer be used. Firm also issued press release: https://www.prnewswire.com/news-releases/whele-llc-announces-national-voluntary-recall-of-mighty-bliss-electric-heating-pad-due-to-product-safety-concerns-301656419.html
Quantity in Commerce 4,034
Distribution US Nationwide through Amazon.com and Walmart.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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