FDA Device Intelligence
Home › BREG, INC. › BREG

BREG

BREG, INC. · Model PAD M/U XL WO · UDI-DI 00672736001073

ILO Prescription
10
510(k) clearances
984
Adverse events (3 deaths)
22
Recalls
125
Facilities

Recalls

DateFirmReason
2026-03-19DJO, LLCDue to broken connector which may result in a temporary interruption of prescribed cold therapy.
2026-03-19DJO, LLCDue to broken connector which may result in a temporary interruption of prescribed cold therapy.
2026-03-19DJO, LLCDue to broken connector which may result in a temporary interruption of prescribed cold therapy.
2026-03-19DJO, LLCDue to broken connector which may result in a temporary interruption of prescribed cold therapy.
2021-11-22Gentherm Medical, LLCThis recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
2019-07-19Cincinnati Sub-Zero Products LLC, a Gentherm CompanyUpdated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause tissue damage
2017-11-07Stryker Medical Division of Stryker CorporationThe 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
2015-01-07Cincinnati Sub-Zero Products IncSeals in the water path of the CT-99 cold therapy pad may separate during use, which could lead to a water leak.
2013-09-17DeRoyal Industries IncThe 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
2013-09-17DeRoyal Industries IncThe 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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.