IntelliCuff recall (Hamilton Medical AG)

Medical deviceClass IIOngoing

Summary: Hamilton Medical AG is recalling IntelliCuff, Portable automatic cuff pressure controller REF: 951001. Reason: 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.

What is being recalled

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

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 named: Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kentucky, Massachusetts, Michigan, North Dakota, Nebraska, New York, Ohio, Pennsylvania, Puerto Rico, South Dakota, Texas, Virginia, Washington, Wisconsin, West Virginia, Wyoming)

How to tell if yours is affected

GTIN: 07630002800839/ Lot # range: 00001 -19732

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Hamilton Medical AG · all medical device recalls · recalls from May 2026

Official FDA record