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IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Class II
Recalling firm
Hamilton Medical AG
Reason for recall
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
Distribution pattern
Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MA, MI, ND, NE, NE, NY, OH, PA, PR, SD, TX, VA, WA, WI, WV, WY and the country of Canada.
State
N/A
Status
Ongoing
Recall number
Z-2625-2026
Recall initiated
May 22, 2026
View on openFDA