Arjohuntleigh Polska Sp Z O O recalls
Arjohuntleigh Polska Sp Z O O appears in 10 official U.S. recall notices indexed by RecallRadar, most recently on 2026-04-22.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 10 |
|---|---|
| Published | 2014-10-01 to 2026-04-22 |
| By agency | FDA Device (10) |
| By classification | Class II (9), Class I (1) |
| By status | terminated (7), ongoing (3) |
| Distribution named in notices | AL, CA, CO, CT, FL, GA, IL, MA, MD, MI, NC, NJ, NV, NY, OH, OK, PA, SD, TN, TX, US, VA, WI |
Recalls
- Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
FDA Device · Class II · 2026-04-22 · Arjohuntleigh Polska Sp Z O O
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 l… - Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module a…
FDA Device · Class II · 2024-01-03 · Arjohuntleigh Polska Sp Z O O
Reason: Unintended movement of bed wheels - Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module a…
FDA Device · Class II · 2024-01-03 · Arjohuntleigh Polska Sp Z O O
Reason: Unintended movement of bed wheels - Sara Plus Active Floor Lift
FDA Device · Class I · 2022-06-01 · Arjohuntleigh Polska Sp Z O O
Reason: The device may emit smoke or ignite. - Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0
FDA Device · Class II · 2021-10-06 · Arjohuntleigh Polska Sp Z O O
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. - Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments
FDA Device · Class II · 2020-08-26 · Arjohuntleigh Polska Sp Z O O
Reason: Modular Junction Box (MJB) cables can melt and affect the bed functionality. - Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483], BAB1007-01 [(01)05…
FDA Device · Class II · 2020-03-18 · Arjohuntleigh Polska Sp Z O O
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 o… - ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended for assisted trans…
FDA Device · Class II · 2018-12-19 · Arjohuntleigh Polska Sp Z O O
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 consequen… - ArjoHuntleigh Sara Combilizer
FDA Device · Class II · 2016-09-14 · Arjohuntleigh Polska Sp Z O O
Reason: ArjoHuntleigh has concluded that a device tipping hazard may occur on the current Sara Combilizer lifting mechanism, providing a potential for risk to the patient or the caregiver. The tipping phenomenon has been found… - Minstrel (with scale) Product Usage: is a mobile passive hoist
FDA Device · Class II · 2014-10-01 · Arjohuntleigh Polska Sp Z O O
Reason: ArjoHuntleigh received three reports where the bolt under the scale unscrewed from the scale. There is a remote risk concerning the bolt unscrewing from the scale. When the scale and bolt parts are not correctly service…