Recalling firm
Hamilton Medical AG
Product type
Device
Status
Ongoing
Report date
2026-07-08
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 state
N/A
Product quantity
962 units
Initiated by
Voluntary: Firm initiated
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.
Product description
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Code / lot info
GTIN: 07630002800839/ Lot # range: 00001 -19732
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.