Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0236-2023Class I

Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001

Whele LLC / initiated 2022-10-24 / Open, Classified / root cause: design

Whele LLC DBA Perch began a recall of Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001 on . FDA classified it as Class I and gives the reason as "The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number
Z-0236-2023
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
Whele LLC
Product
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
Product code
IRT Pad, Heating, Powered
Reason for recall
The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.
Root cause tag
design
FDA root cause
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
528,067
Distribution
US Nationwide through Amazon.com and Walmart.
Product codes and lots
No UDI Lots: 210108 210305 210805 211002 210109 210306 210806 211003 210110 210307 210901 211004 210111 210308 210902 211005 210201 210309 210904 211006 210202 210310 210905 211007 210203 210405 210906 211008 210204 210406 210903 211009 210301 210407 210907 211010 210401 210501 210908 211101 210402 210502 210909 211102 210403 210801 210910 211103 210302 210802 210911 211104 210303 210803 210912 211105 210304 210804 211001 211106 211107 211108 211201 211202 211203 211204 211205 211206 211207 220101 220201 220103

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0236-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0236-2023Class IOngoingVoluntary: Firm initiated
Z-0237-2023Class IOngoingVoluntary: Firm initiated
Z-0238-2023Class IOngoingVoluntary: Firm initiated