Pad, Heating, Powered
Physical Medicine · 21 CFR 890.5740
Recent MDR events
6,878 adverse event reports on file
- SunbeamJul 30, 2026InjurySunbeam Products, Inc.3010805625-2026-00021
- SUNBEAMJul 14, 2026InjurySunbeam Products, Inc.3010805625-2026-00020
- SUNBEAMJul 13, 2026InjurySunbeam Products, Inc.3007790958-2026-00019
- WALGREENS KING SIZE HEATING PADJul 10, 2026InjuryEagle Electric Co., Ltd3011077581-2026-00001
- SUNBEAMJul 9, 2026InjurySunbeam Products, Inc.3007790958-2026-00018
- UTKJul 5, 2026InjuryUtk Technology Shen Zhen Limited3011164092-2025-00059
- SUNBEAMJul 2, 2026InjurySunbeam Products, Inc.3007790958-2026-00017
- SUNBEAMJun 25, 2026InjurySunbeam Products, Inc.3010805625-2026-00016
- RICHWAY FUJI BIOMAT MINI 7000MXJun 17, 2026MalfunctionRichway & Fuji Bio Inc.MW5189524
- DMI - XL ELECTRIC HEATING PADJun 15, 2026MalfunctionCardicare1000143485-2026-29201
Event type breakdown
Most-reported manufacturers
Recalls
24 recall events for this product code
- Navajo Manufacturing CompanyOpen, ClassifiedMar 21, 2026
Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico Products Co., Ltd
If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property.
Z-1588-2026 · View FDA record ↗ - EYE COMFORT CARE LLCCompletedAug 14, 2024
Brand Name: UNclog Eye Mask
Due to a change in the safety clips for the heated eye masks, the wires to the safety clips may detach as a result of tugging and pulling and may cause a short in the heating element of the mask and could potentially cause burn injuries.
Z-2586-2024 · View FDA record ↗ - Whele LLC DBA PerchOpen, ClassifiedNov 23, 2022
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Blue Electric Heating Pad, MB-001
The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.
Z-0236-2023 · View FDA record ↗ - Whele LLC DBA PerchOpen, ClassifiedNov 23, 2022
Mighty Bliss Electric Heating Pad, Extra-Large (20 x 24 ) Blue Electric Heating Pad, MB-002
The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.
Z-0237-2023 · View FDA record ↗ - Whele LLC DBA PerchOpen, ClassifiedNov 23, 2022
Mighty Bliss Electric Heating Pad, Large (12 x 24 ) Grey Electric Heating
The products may have the potential to burn customers. Firm has received complaints of burns, mild shocks, and rashes/irritation.
Z-0238-2023 · View FDA record ↗ - HoMedics, Inc.TerminatedMar 21, 2007
HoMedics Thera P Standard size Dry Heating Pad; Model No. HP-100 (UPC 031262003621).
Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
Z-0622-2007 · View FDA record ↗ - HoMedics, Inc.TerminatedMar 21, 2007
HoMedics Thera-P Standard size Moist/Dry Heating Pad, Model No. HP-150 (UPC 031262003638) and sold as Walgreens by Homedics model number 802857 (UPC 04922149892
Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
Z-0623-2007 · View FDA record ↗ - HoMedics, Inc.TerminatedMar 21, 2007
HoMedics Thera P Standard size Moist/Dry Heating Pad with Auto Shut-off, Model No. HP-200 (UPC 031262007926).
Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
Z-0624-2007 · View FDA record ↗ - HoMedics, Inc.TerminatedMar 21, 2007
HoMedics Thera P King size Moist/Dry Heating Pad; Model No. HP-300 (UPC 031262003645).
Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
Z-0625-2007 · View FDA record ↗ - HoMedics, Inc.TerminatedMar 21, 2007
HoMedics Thera P Model King size Moist/Dry Heating Pad with Auto Shut-off; Model No. HP-500 (UPC 031262003652).
Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
Z-0626-2007 · View FDA record ↗
Registered firms
293 firms currently registered for this product code
Advanced Healthcare Technology Limited
Waltham Cross Hertfordshire, GB
Praywise Technology (dongguan) Co., Ltd
Dongguan City Guangdong, CN
Top Longmax Products Co., Ltd.
TAICHUNG, TW
Arlington Scientific, Inc.
SPRINGVILLE, UT, US
Nuga Medical Co Ltd
Wonju Gangwon, KR
Weero Co., Ltd.
Suwon-si,Gyeonggi-do, KR
Ogawa Wellness Vietnam Company Limited
Long An, VN
Zhejiang Dingda Industrial Co.,ltd
Lishui Zhejiang, CN
Richway & Fuji Bio Inc.
Honolulu, HI, US
Djo, Llc
Carlsbad, CA, US
Shenzhen Combei Technology Co.,ltd.
Shenzhen Guangdong, CN
Quantmed Lifetech (shenzhen) Co., Ltd.
ShenzhenCity Guangdong, CN
Jiangsu Fangxiangji Textile Technology Co.,ltd
yancheng Jiangsu, CN
Grahope New Materials Technologies Inc.
Shenzhen Guangdong, CN
Shenzhen Yicai Health Technology Co. , Ltd
Shenzhen Guangdong, CN
Espansione Marketing Spa
CREVALCORE Bologna, IT
Zhejiang Lumeng Health & Technology Co.,ltd Shao Xing Pao Jiang Branch
Shaoxing Zhejiang, CN
Mibo Medical Group
Irving, TX, US
Beijing Eternal Medical Technology Co.,ltd.
Beijing, CN
Shenzhenshi Hengmeite Technology Co., Ltd.
Shen zhen Guangdong, CN
Shenzhen Micro Electric Intelligence Co., Ltd.
Shenzhen Guangdong, CN
Life Wear Technologies, Inc.
Pompano Beach, FL, US
Aoj Health Technology Co., Ltd.
Shenzhen Guangdong, CN
King Brand Healthcare Products
Bellingham, WA, US
Apothecaries Sundries Mfg Pvt Ltd
GURUGRAM Haryana, IN
510(k) clearances
42 clearances for this product code
- mibeTec GmbHSep 12, 2025
K250047 · bite away two
- mibeTec GmbHJun 23, 2022
K220514 · bite away neo
- Riemser PharmaAug 26, 2016
K160943 · Bite Away
- Digital Heat CorporationFeb 9, 2015
K142228 · Heated Eye Pad
- Avacen, Inc.Aug 15, 2014
K133981 · AVACEN 100
- Shenzhen Anpan Technology Co., Ltd.Nov 8, 2011
K111273 · FIR HEAT THERAPHY SYSYEMS
- Richway Intl., Inc.Feb 8, 2008
K072534 · BIO-MAT 2000
- Anthony A. ChiurcoMar 31, 1997
K963887 · PT-PAC PORTABLE HEATING PAD