FDA recall, , Moderate risk
Hamilton Medical IntelliCuff Portable Automatic Cuff Pressure Controller
The IntelliCuff portable automatic cuff pressure controller may alarm with a leakage error and fail to maintain pressure.
Summary by Recall Canary from the FDA notice
What happened
Hamilton Medical AG, based in Domat/Ems, Switzerland, began a recall on May 22, 2026, of the IntelliCuff, Portable automatic cuff pressure controller REF: 951001, after reported complaints that the device may alarm with a 'Cuff System Leakage' error, causing the motor to pump continuously and fail to maintain the cuff pressure set by the user. The recall was added to the FDA's Enforcement Report and classified on July 1, 2026, and in the FDA's weekly enforcement report on July 8, 2026.
The recalled device was distributed worldwide, including nationwide in the U.S. across states such as Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kentucky, Massachusetts, Michigan, North Dakota, Nebraska, New York, Ohio, Pennsylvania, South Dakota, Texas, Virginia, Washington, Wisconsin, West Virginia, and Wyoming, as well as Canada.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
- UDI-DI
- 07630002800839
- Lot code
- 00001
- 19732
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kentucky, Massachusetts, Michigan, North Dakota, Nebraska, Nebraska, New York, Ohio, Pennsylvania, PR, South Dakota, Texas, Virginia, Washington, Wisconsin, West Virginia, Wyoming and the country of Canada.
- Company
- Hamilton Medical AGDomat/Ems, Switzerland
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99035
- Recall number
- Z-2625-2026
- Quantity recalled
- 962 units
All recalls from Hamilton Medical AG
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
