Komorniki, N/A, Poland
ARJOHUNTLEIGH POLSKA Sp. z.o.o. recalls
7 recalls recorded since 2018, most recently on 10 March 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls7
Ongoing (FDA)2
Terminated or completed5
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 10 March 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1811-2026
- Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
Ongoing Class II Medical devices
- Recall started
- 29 August 2023
- Reason
- Unintended movement of bed wheels
- Distribution
- US: TN, CA, NY, IL, NV, PA, SD
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0611-2024, Z-0612-2024
- Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
- Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
Terminated Class I Medical devices
- Recall started
- 5 April 2022
- Terminated
- 5 September 2024
- Reason
- The device may emit smoke or ignite.
- Distribution
- US Nationwide and Worldwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1098-2022
- Sara Plus Active Floor Lift
Terminated Class II Medical devices
- Recall started
- 10 June 2021
- Terminated
- 3 February 2026
- Reason
- The IndiGo power cord might wear during use which could lead to its damage, resulting in the cord being cut, burnt or short circuit with limited emission of sparks.
- Distribution
- US Nationwide distribution in the states of CA, FL, IL, KY, MD, NV, NY, PA, and SD.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2588-2021
- Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (mode
Terminated Class II Medical devices
- Recall started
- 21 July 2020
- Terminated
- 17 February 2021
- Reason
- Modular Junction Box (MJB) cables can melt and affect the bed functionality.
- Distribution
- Worldwide distribution: US (nationwide) to states of:: FL, KS, LA and countries of:: Australia, Brazil, Canada, France and Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2821-2020
- Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
Terminated Class II Medical devices
- Recall started
- 22 August 2019
- Terminated
- 15 February 2022
- Reason
- The firm has become aware that any of the 4 safety catches may exhibit a mechanical failure (break in one of the arms of safety catch), which in certain circumstances may contribute to the side support unintentionally opening and may lead to a potential risk of a patient fall. The patient falling could lead to various types of injuries.
- Distribution
- US: CA, CO, CT, GA, MA, MD, MI, NC, NJ, NY, OH, OK, TX, VA, WI OUS: Australia Austria, Bangladesh, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Iceland, India, Ireland, Italy, Japan, Korea, Luxembourg, Netherlands, Netherlands/CW, New Zealand, Norway, Philippines,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1452-2020
- Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05055982796255], BAB1101-01 [(01)05055982787949], BAB1102-01 [(01)05055982796156],
Terminated Class II Medical devices
- Recall started
- 22 October 2018
- Terminated
- 19 May 2021
- Reason
- Inspection process at the manufacturer found nonwoven material was used in specific lots of product that may break wile in use during the patient/resident transfer. Patient/resident might fall on the floor. IN consequence, the patient might sustain a major trauma, head injury - damage to tissue that is irreversible or may lead to death.
- Distribution
- US nationwide distribution in the state of WV. OUS: Information not provided due to the product being manufactured OUS and imported to US
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0589-2019
- ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted transfer of patient/resident with limited ability to move. Designed to be used for o
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.