FDA Medical devices recall ·
IntelliCuff, Portable automatic cuff pressure controller recall
- Recall number
- Z-2625-2026
- Date
- (initiated May 22, 2026)
- Company / brand
- Hamilton Medical AG
Parc Industrial Vial 10, Domat/Ems, N/A, Switzerland - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 962 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Arizona California Colorado Florida Georgia Hawaii Illinois Kentucky Massachusetts Michigan North Dakota Nebraska New York Ohio Pennsylvania Puerto Rico South Dakota Texas Virginia Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2625-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.