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Recall Observatory FDA recall evidence

Device product

IntelliCuff, Portable automatic cuff pressure controller REF: 951001

Z-2625-2026

May 22, 2026

Class II

Product summary

Firm
Hamilton Medical AG
Event
Event 99035
Status
Ongoing
Classification
Class II
Quantity
962 units
Official record key
device-enforcement:Z-2625-2026

Official wording

Reason: 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.

Code information: GTIN: 07630002800839/ Lot # range: 00001 -19732

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.