FDAFDA · Food and drugs·Recall number Z-2625-2026
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Published July 8, 2026 · Recall initiated: May 22, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Hamilton Medical AG
- Distributor
- 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.
- Lot
- GTIN: 07630002800839/ Lot # range: 00001 -19732
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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