Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
Summary
The FDA issued a Class I for Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, 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-0236-2023
Action Date
2022-11-30
Status
Ongoing
Category
device
Product Description
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
Lot/Code Info: 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
Quantity Affected: 528,067
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-0236-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29