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FDAClass II · Medical device · Recalled July 8, 2026
IntelliCuff recall — Hamilton Medical AG
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.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2625-2026
- Brand
- Hamilton Medical AG
- Classification
- Class II
- Units affected
- 962 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Affected products
Companies & origin
- Recalling firm location
- Domat/Ems, N/A, Switzerland
- Firm address
- Parc Industrial Vial 10, N/A, N/A
Identifying details (verbatim from the notice)
- Product codes / lots
- GTIN: 07630002800839/ Lot # range: 00001 -19732
- 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.
- Firm notified the public via
- Letter
- FDA event ID
- 99035
- Recall initiated
- May 22, 2026
- FDA classified
- July 1, 2026
- FDA report date
- July 8, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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