The recall described in this notice is for the same issue that was announced in Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication | FDA on October 25, 2022.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Name: Mighty Bliss electric heating pads
- Product Model Numbers:
- Distribution Dates: July 29, 2021 to July 21, 2022
- Devices Recalled in the U.S.: 544,212
- Date Initiated by Firm: October 24, 2022
Mighty Bliss electric heating pads produce heat through electrical elements. These devices are flexible and may include heat-retaining material such as gel, fluid, or vegetable matter to help distribute the heat evenly across the heating pad surface. They are used for temporary relief of aches and pains.
Reason for Recall
Whele LLC is recalling Mighty Bliss electric heating pads after receiving customer complaints related to the product burning customers' skin, overheating, sparking, burning, or presenting other electrical problems.
Use of the recalled Mighty Bliss electric heating pads could lead to serious adverse events including infections, scar tissue from a skin contraction, skin irritation, skin burns, electric shock, and fire.
Whele LLC reported 286 customer complaints between July 2021 and September 2022 related to this recall. There have been 31 reported injuries such as electric shocks, burns, and skin burns, rashes or irritation. There are no reports of deaths related to this issue.
Who May be Affected
- Patients, caregivers, and health care providers who may have and use the recalled Mighty Bliss electric heating pads.
What to Do
On October 24, 2022, Whele LLC sent customers an Urgent Product Recall notice and a press release to alert people to this issue. The company recommended that customers/users take several actions:
- Check your heating pad to determine if you have a recalled Mighty Bliss electric heating pad. If you have this product, stop using it and follow the recommendations in the recall notice.
- Do NOT use the recalled Mighty Bliss electric heating pads.
- Do NOT purchase the recalled Mighty Bliss electric heating pads.
- Verify receipt of the recall notification at the Whele LLC website: https://www.mightyblissheatingpadrecall.expertinquiry.com/, even if you no longer have the product on hand.
The announcement also included actions to be taken by distributors:
- Examine inventory and quarantine the recalled products. Whele LLC will contact distributors to collect remaining inventory for destruction.
- Identify customers who may have received affected products.
- Notify customers within two business days of the product recall, include the following URL: www.mightyblissheatingpadrecall.expertinquiry.com.
Consumers with questions can call 866-918-8768, Monday through Friday from 8am to 5pm EST, or email firstname.lastname@example.org.
- Whele LLC Announces Voluntary Recall of Mighty Bliss Electric Heating Pad Due to Product Safety Concerns (Company Announcement)
- Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury (FDA Safety Communication)
- Recall Database entries:
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.