Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001

FDA Device Recall #Z-0236-2023 — Class I — October 24, 2022

Recall Summary

Recall Number Z-0236-2023
Classification Class I — Serious risk
Date Initiated October 24, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Whele LLC DBA Perch
Location Boston, MA
Product Type Devices
Quantity 528,067

Product Description

Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001

Reason for Recall

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

Distribution Pattern

US Nationwide through Amazon.com and Walmart.

Lot / Code Information

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

Other Recalls from Whele LLC DBA Perch

Recall # Classification Product Date
Z-0237-2023 Class I Mighty Bliss Electric Heating Pad, Extra-Large ... Oct 24, 2022
Z-0238-2023 Class I Mighty Bliss Electric Heating Pad, Large (12 x... Oct 24, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.