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RegeniCool™ Pro

Unite Medical, LLC · Model RC-PRO-1000 · UDI-DI 00850063323567

ILO

510(k) clearances

1,008

Adverse events (3 deaths)

Recalls

125

Facilities

Description

RegeniCool™ Pro is a cold compression therapy system intended to provide localized cold therapy through circulating chilled water for the temporary reduction of pain and swelling following surgery or injury. The system consists of a portable base unit with an integrated reservoir and pump that circulates chilled water through a compatible therapy wrap applied to the treatment area. The device offers adjustable therapy settings that control water circulation timing and hydraulic pressure within the wrap. It is intended for use in clinical or home settings under the direction of a licensed healthcare provider. The device does not utilize pneumatic (air-driven) compression. Compatible wraps are packaged separately.

Recalls

Date	Firm	Reason
2026-03-19	DJO, LLC	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
2026-03-19	DJO, LLC	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
2026-03-19	DJO, LLC	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
2026-03-19	DJO, LLC	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
2021-11-22	Gentherm Medical, LLC	This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
2019-07-19	Cincinnati Sub-Zero Products LLC, a Gentherm Company	Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
2017-11-07	Stryker Medical Division of Stryker Corporation	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 maintenanc
2015-01-07	Cincinnati Sub-Zero Products Inc	Seals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.
2013-09-17	DeRoyal Industries Inc	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 t
2013-09-17	DeRoyal Industries Inc	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 t

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.