FDA recall Z-1811-2026

ARJOHUNTLEIGH POLSKA Sp. z.o.o. · Class II · device

Product

Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US

Reason for recall

An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2026-03-10
Report date
2026-04-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Komorniki, N/A, Poland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1811-2026