Class II

Medical Device Recall: IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Hamilton Medical AG · May 22, 2026

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

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.

States Affected

NATIONWIDE

Quantity Affected

962 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2625-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Hamilton Medical AG Medical Device Recall: IntelliCuff, Portable automatic cuff pressure controller REF: 951001 | SafeCheck