FDA Device Recall Z-0238-2023

Whele LLC DBA Perch · Boston, MA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating Pad, PE-MtyBls-HeatPad-12x24-Gry-V2

Lot / serial / GTIN: No UDI Lots: 220103

Quantity: 4,034

Reason for recall

The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.

Recall record

Recall number: Z-0238-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: US Nationwide through Amazon.com and Walmart.
Recall initiated: 2022-10-24
Classified by FDA Center: 2022-11-23
FDA published: 2022-11-30
Recalling firm: Whele LLC DBA Perch
Firm location: Boston, MA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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