FDAFDA recall Z-2625-2026 · Jul 8, 2026
Hamilton Medical AG: IntelliCuff recall
Recall found
Product
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- GTIN: 07630002800839/ Lot # range: 00001 -19732
- Quantity
- 962 units
- Distribution
- 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.
- Recalling firm
- Hamilton Medical AG, Domat/Ems, N/A
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-22
Source: openFDA enforcement record Z-2625-2026 · search recall number Z-2625-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.