Can cause harm that is usually temporary.

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Check the device or its packaging for

Why

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.

Distributed

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.

Company

Hamilton Medical AG

Announced

8 July 2026This is the date the recall was announced. A company may have started it weeks earlier.

Recall began

22 May 2026

Source: FDA record Z-2625-2026 · retrieved 1 July 2026