Pack, Hot Or Cold, Water Circulating
Physical Medicine · 21 CFR 890.5720
Recent MDR events
984 adverse event reports on file
- DONJOYJul 6, 2026InjuryDjo Llc9616086-2026-00025
- T PUMPJan 26, 2026InjuryC2dx Inc.3015489752-2026-00001
- BREG POLAR CAREJan 15, 2026MalfunctionBreg, Inc.24078673
- THERMAZONE THERMAL THERAPYOct 27, 2025MalfunctionInnovative Medical EquipmentMW5177985
- MUL-T-PADSep 17, 2025MalfunctionC2dx, Inc.23073093
- T PUMPSep 15, 2025MalfunctionC2dx Inc.3015489752-2025-00001
- KPADJul 30, 2025MalfunctionStryker CorporationMW5173537
- BLANKETROL III HYPER-HYPOTHERMIA MACHINEMay 16, 2025InjuryGentherm Medical, LlcMW5170532
- MEDIFROSTMay 14, 2025MalfunctionChengdu Cryo-push Medical Technology Co.,ltd3011491271-2025-00001
- AIRCASTApr 1, 2025InjuryDjo Llc9616086-2025-00035
Event type breakdown
Recalls
22 recall events for this product code
- DJO, LLCOpen, ClassifiedMay 8, 2026
Brand Name: DONJOY
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Z-2134-2026 · View FDA record ↗ - DJO, LLCOpen, ClassifiedMay 8, 2026
Brand Name: DONJOY
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Z-2135-2026 · View FDA record ↗ - DJO, LLCOpen, ClassifiedMay 8, 2026
Brand Name: DONJOY
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Z-2136-2026 · View FDA record ↗ - DJO, LLCOpen, ClassifiedMay 8, 2026
Brand Name: DONJOY
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Z-2137-2026 · View FDA record ↗ - Stryker Medical Division of Stryker CorporationTerminatedMar 14, 2018
T/Pump temperature therapy pump, Models TP700 and TP700C
The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenance to the Indications for Use statement.
Z-1013-2018 · View FDA record ↗ - Cincinnati Sub-Zero Products IncTerminatedFeb 19, 2015
Cold Therapy Pad - cold water circulating pad, one unit per package.
Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.
Z-1129-2015 · View FDA record ↗ - DeRoyal Industries IncTerminatedJan 27, 2014
Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China.
The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
Z-0834-2014 · View FDA record ↗ - DeRoyal Industries IncTerminatedJan 27, 2014
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powe
The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
Z-0835-2014 · View FDA record ↗ - DeRoyal Industries IncTerminatedJan 27, 2014
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell
The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
Z-0836-2014 · View FDA record ↗ - DeRoyal Industries IncTerminatedJan 27, 2014
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Pow
The unit displays an error code of hose kinking when no hose kink is present; the unit fails to monitor the temperature of the water in the blanket as intended and controlling it through the automatic temperature control. This failure could result in temperature injuries to the treatment site; and there have been two reports of electric shock.
Z-0837-2014 · View FDA record ↗
Registered firms
158 firms currently registered for this product code
Avent S. De R.l. De C.v.
TIJUANA Baja California, MX
Guangzhou Four E's Scientific Co., Ltd.
GUANGZHOU Guangdong, CN
Ivy Technology
Jeffersontown, KY, US
Polar Products Inc
Stow, OH, US
Daesung Maref Co.,ltd
Anyang-si Gyeonggi, KR
Deroyal Industries, Inc.
POWELL, TN, US
Zhejiang E-cozy Electronic Technology Co., Ltd.
Wenzhou Zhejiang, CN
Chengdu Cryo-push Medical Technology Co.,ltd
CHENGDU Sichuan, CN
Acot Plastics (xiamen) Co., Ltd.
XIAMEN Fujian, CN
Pride Industries
Roseville, CA, US
Gener8
San Jose, CA, US
Health Source Medical Equipment (guangdong) Ltd.
Foshan Guangdong, CN
Ultra Pain Products, Inc.
Albertson, NY, US
Shanghai Leison Medical & Healthcare Products Co., Ltd
Shanghai, CN
C2dx, Inc.
Schoolcraft, MI, US
Zenith Technical Innovations, Llc
Gurnee, IL, US
Shenzhen Ruiyi Business Technology Co., Ltd.
Shenzhen Guangdong, CN
Comfortland International, Llc
Mebane, NC, US
Zhongshan First Medical Equipment Co., Ltd
Zhongshan Guangdong, CN
Breg Mexico, S. De R.l. De C.v. (3)
Mexicali Baja California, MX
Vive Health Llc
Naples, FL, US
Hangzhou Yunchi Technology Co., Ltd
Hangzhou Zhejiang, CN
Ermi Llc
ATL, GA, US
510(k) clearances
93 clearances for this product code
- Pain Management Technologies, Inc.Jun 10, 2022
K213097 · Armory Motion
- Elbio Co., Ltd.Jun 10, 2009
K083008 · COOLSKIN
- Gaymar Industries, Inc.May 8, 2008
K073675 · T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP
- Juniper Medical, Inc.Sep 7, 2007
K072152 · JUNIPER CLN1 DERMAL COOLING DEVICE
- Breg, Inc.Mar 29, 2007
K070402 · MODIFICATION TO POLAR CARE 500
- Mark H. FriedmanMay 7, 2004
K040317 · IVC SYSTEM
- Hollister, Inc.Nov 3, 1997
K973023 · INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET
- Adroit Medical Systems, Inc.Sep 10, 1997
K970197 · HTP-1500 LOCALIZED HEAT THERAPY PUMP