FDAClass II · Medical device · Recalled July 8, 2026

IntelliCuff recall — Hamilton Medical AG

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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2625-2026
Brand: Hamilton Medical AG
Classification: Class II
Units affected: 962 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Affected products

IntelliCuff

Companies & origin

Recalling firm location: Domat/Ems, N/A, Switzerland
Firm address: Parc Industrial Vial 10, N/A, N/A

Identifying details (verbatim from the notice)

Product codes / lots: GTIN: 07630002800839/ Lot # range: 00001 -19732
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.
Firm notified the public via: Letter
FDA event ID: 99035
Recall initiated: May 22, 2026
FDA classified: July 1, 2026
FDA report date: July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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