CLASS II ONGOING Device recall · Reported 8 Jul 2026 · FDA Enforcement Report

IntelliCuff, Portable automatic cuff pressure controller recalled

Hamilton Medical AG is recalling IntelliCuff, Portable automatic cuff pressure controller, distributed nationwide in the US. The recall was initiated on 22 May 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 07630002800839/ Lot # range: 00001 -19732

Quantity recalled962 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2625-2026
FDA event ID: 99035
Recalling firm: Hamilton Medical AG, Domat/Ems, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 22 May 2026
FDA classified: 1 Jul 2026
Reported: 8 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

22 May 2026	Recall initiated by company
1 Jul 2026	Classified by FDA	+40 days
8 Jul 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Where it was distributed

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.

Nationwide Arizona California Colorado Florida Georgia Hawaii Illinois Kentucky Massachusetts Michigan North Dakota Nebraska New York Ohio Pennsylvania Puerto Rico South Dakota Texas Virginia Washington

Questions about this recall

Is IntelliCuff, Portable automatic cuff pressure controller recalled?

Yes. Hamilton Medical AG recalled IntelliCuff, Portable automatic cuff pressure controller on 22 May 2026. The recall is Class II and its status is Ongoing. Recall number Z-2625-2026.

Why was it 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.

Which lots are affected?

GTIN: 07630002800839/ Lot # range: 00001 -19732

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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