Reported Jul 8, 2026 · Ongoing

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Hamilton Medical AG

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hamilton Medical AG · Parc Industrial Vial 10 · Domat/Ems, N/A · N/A

Is this the product you have?

  • IntelliCuff, Portable
  • automatic cuff pressure controller REF951001
Lot codes and dates
  • GTIN07630002800839/ Lot #
  • range00001 -19732
Amount recalled
962 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.