Z-2625-2026 Class II Ongoing
FDA device recall Z-2625-2026 was initiated by Hamilton Medical AG on May 22, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 962 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 8, 2026
- Initiation Date
- May 22, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 962 units
Product Description
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.
Distribution Pattern
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.
Code Information
GTIN: 07630002800839/ Lot # range: 00001 -19732