The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2625-2026·Announced 2026-07-08

IntelliCuff Portable Automatic Cuff Pressure Controller Recall

Hamilton Medical AG is recalling the IntelliCuff portable automatic cuff pressure controller due to a reported "Cuff System Leakage" error that may cause the motor to pump continuously and fail to maintain user-set cuff pressure.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving a medical device whose malfunction (continuous motor pumping, failure to maintain cuff pressure) creates a risk of patient harm. Although no illnesses or injuries are explicitly reported in the source text, the functional failure of a cuff-pressure control device presents a risk of adverse health consequences. This meets the High criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Hamilton Medical AG is recalling the IntelliCuff, Portable automatic cuff pressure controller (REF: 951001) due to reported complaints of a "Cuff System Leakage" error. When this error occurs, the motor may pump continuously and fail to maintain the cuff pressure set by the user.

Approximately 962 units have been distributed nationwide in the United States, including 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, and Wyoming, as well as Canada. The affected units fall within lot number range 00001–19732 (GTIN: 07630002800839).

Users of affected IntelliCuff devices should contact Hamilton Medical AG or their healthcare provider for guidance on device management and potential replacement options.

The recalled product

Product
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Manufacturer
Hamilton Medical AG
Category
Medical Device — Portable Cuff Pressure Control
Hazard
Affected units
962

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • GTIN: 07630002800839/ Lot # range: 00001 -19732

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically:

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