ARJOHUNTLEIGH POLSKA Sp. z.o.o. FDA Recalls

5 recalls on file across devices, 1 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 USClass IIMar 10, 2026An internal component of the actuators in a certain producti	An internal component of the actuators in a certain production batch may not meet the required mechanical stre	Class IIDevices	Mar 10, 2026
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Class IIAug 29, 2023Unintended movement of bed wheels	Unintended movement of bed wheels	Class IIDevices	Aug 29, 2023
Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Class IIAug 29, 2023Unintended movement of bed wheels	Unintended movement of bed wheels	Class IIDevices	Aug 29, 2023
Sara Plus Active Floor LiftClass IApr 5, 2022The device may emit smoke or ignite.	The device may emit smoke or ignite.	Class IDevices	Apr 5, 2022
Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndClass IIJun 10, 2021The IndiGo power cord might wear during use which could lead	The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, b	Class IIDevices	Jun 10, 2021