FDA recall Z-2625-2026

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2026-05-22

Report date

2026-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Domat/Ems, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2625-2026