Drug recall

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

FDA recall event 99035 · Class II · Hamilton Medical AG

Key facts

Event ID 99035
Recall numbers Z-2625-2026
Recalling firm Hamilton Medical AG
Product type Devices
Products IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Classification Class II
Status Ongoing
Voluntary or mandated Firm Initiated
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.
Initiation date May 22, 2026
Report date Jul 8, 2026
City Domat/Ems
Country Switzerland
FEI number 3014766741

At a glance

  • 1–9 Products in this recall
  • 1–9 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA drug and product recalls

FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.

Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date:

Browse all FDA drug and product recalls