Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002
Summary
The FDA issued a Class I for Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating by Whele LLC DBA Perch. Reason: The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation..
Details
Source
Device Recall
External ID
Z-0237-2023
Action Date
2022-11-30
Status
Ongoing
Category
device
Product Description
Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002
Lot/Code Info: No UDI Lots: 210901 211001
Quantity Affected: 12,140
Reason for Recall
The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.
Distribution
US Nationwide through Amazon.com and Walmart.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-24
Company
Boston, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Whele LLC DBA Perch has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Whele LLC DBA Perch) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Whele LLC DBA Perch have FDA actions?
Whele LLC DBA Perch has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0237-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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