FDAHealthMay 22, 2026
Hamilton Medical AG — IntelliCuff, Portable automatic cuff pressure controller REF: 951001
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 22, 2026
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's affected?
- Product
- IntelliCuff, Portable automatic cuff pressure controller REF: 951001
- Brand
- Hamilton Medical AG
- Lot code
- range:
Additional details
GTIN: 07630002800839/ Lot # range: 00001 -19732
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 962 units.
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