174 results · 26ms · Sources: EU EUDAMED, US FDA

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Electri-Cool II

FDA Recall
Terminated ·Cincinnati Sub-Zero Products Inc·Product code ILO·January 18, 2005

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.

FDA Recall
Terminated ·DeRoyal Industries Inc·Product code ILO·September 17, 2013

Cold Therapy Blanket

FDA Recall
Terminated ·DeRoyal Technologies Inc·Product code ILO·November 22, 2004

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, Powell, TN 37849. Physical Therapy.

FDA Recall
Terminated ·DeRoyal Industries Inc·Product code ILO·September 17, 2013

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,NS,RH The IceMan CLASSIC3 cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No

FDA Recall
Open, Classified ·DJO, LLC·Product code ILO·March 19, 2026

Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. The owner's manual is labeled in part: "PRO TRAINERS' CHOICE COMPANY, INC.***www.precisionice.com***[email protected]***Mailing Address PO Box 27***Kingston, WA 98346 USA***Phone: 360-297-3902***Shipping Address***26129 Calvary Lane NE, Suite 200***Kingston, WA 98346 USA***Fax: 360-297-3903". The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***".

FDA Recall
Terminated ·Pro Trainers' Choice Company·Product code ILO·April 18, 2011

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, TN 37849. Physical Therapy.

FDA Recall
Terminated ·DeRoyal Industries Inc·Product code ILO·September 17, 2013

Micro-temp II heat therapy unit, model #747.

FDA Recall
Terminated ·Cincinnati Sub-Zero Products Inc·Product code ILO·January 18, 2005

Power Supply Accessory (model AD-0660G) Power supply accessory is used with the Polar Care Kodiak unit, a motorized cold-therapy device. The Power Supply is plugged into a standard electrical wall socket and provides low voltage power to the Kodiak unit. The power supply is not used with other Polar Care models such as PC300 and PC500.

FDA Recall
Terminated ·Breg Inc, An Orthofix Company·Product code ILO·June 18, 2009

Cold Therapy Pad - cold water circulating pad, one unit per package. The pads are used to provide a patient with local cold therapy by circulating chilled water through the pad that has been positioned on the patient.

FDA Recall
Terminated ·Cincinnati Sub-Zero Products Inc·Product code ILO·January 7, 2015

BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.

FDA Recall
Terminated ·Breg Inc·Product code ILO·January 14, 2013

T/Pump temperature therapy pump, Models TP700 and TP700C

FDA Recall
Terminated ·Stryker Medical Division of Stryker Corporation·Product code ILO·November 7, 2017

Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193

FDA Recall
Terminated ·Gentherm Medical, LLC·Product code ILO·November 22, 2021

MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.

FDA Recall
Terminated ·Cincinnati Sub-Zero Products LLC, a Gentherm Company·Product code ILO·July 19, 2019

Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH The IceMan CLASSIC3 cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No

FDA Recall
Open, Classified ·DJO, LLC·Product code ILO·March 19, 2026

TempPad Cold Therapy Pad. The device is used for localized temperature therapy including hand, elbow, arm, foot, ankle, leg, or knee.

FDA Recall
Terminated ·Cincinnati Sub-Zero Products Inc·Product code ILO·November 14, 2009

DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.

FDA Recall
Terminated ·DeRoyal Industries Inc·Product code ILO·September 17, 2013

BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.

FDA Recall
Terminated ·Breg Inc·Product code ILO·January 14, 2013

Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH The IceMan CLASSIC3 cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology. Component: No

FDA Recall
Open, Classified ·DJO, LLC·Product code ILO·March 19, 2026

Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.

FDA Recall
Terminated ·DeRoyal Industries Inc·Product code ILO·September 17, 2013