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IntelliCuff Portable Cuff Pressure Controller
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MEDICAL DEVICE RECALLMODERATE

IntelliCuff Portable Cuff Pressure Controller

The IntelliCuff pressure controller may fail to maintain cuff pressure due to a system leakage error, causing the motor to run continuously.

What to do

Stop using the affected device and contact Hamilton Medical for further instructions or a replacement.

Recalled
Listed
Updated
Recall No.
Z-2625-2026
Agency
FDA
Firm
Hamilton Medical AG
Recall ID
99035
Status
ONGOING

Recall at a glance

Quantity recalled
962 units

Why it was recalled

The IntelliCuff portable automatic cuff pressure controller may experience a "Cuff System Leakage" error, causing the motor to run continuously and fail to maintain the user-set cuff pressure. This malfunction can lead to inadequate cuff inflation.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Lot code
00001, 19732
UDI-DI
07630002800839

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-07-02 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification