FDA Device Recall Z-0236-2023

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 ) Blue Electric Heating Pad, MB-001

Lot / serial / GTIN: 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: 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.

Recall record

Recall number: Z-0236-2023
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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