FDA-Device2026-07-08Class IIPROCESSING DEFECT
Hamilton Medical IntelliCuff cuff pressure controller recalled for motor malfunction risk
What this means
The IntelliCuff portable cuff pressure controller may display a "Cuff System Leakage" error and cause the motor to pump continuously instead of maintaining the pressure set by the user. This can prevent the device from working as intended.
- Check if your device is a Hamilton Medical IntelliCuff (REF: 951001) with lot number 00001–19732
- Contact Hamilton Medical or your healthcare provider for instructions on repair or replacement
- Do not rely on the device if you experience the leakage error
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
962 units
Manufactured in
Parc Industrial Vial 10, N/A, Domat/Ems, N/A, Switzerland
Products
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2625-2026More Hamilton Medical AG recalls
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