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FDA (Device enforcement)Recalled 2026-05-22class ii

Hamilton Medical AG: IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Hazard

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.

Details from the source

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. Quantity: 962 units Lot/code info: GTIN: 07630002800839/ Lot # range: 00001 -19732

UPC codes

07630002800839

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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