Recall Register

ARJOHUNTLEIGH POLSKA Sp. z.o.o.: FDA recalls

FDA enforcement reports name ARJOHUNTLEIGH POLSKA Sp. z.o.o. as the recalling firm in 9 events. The events have 10 product records. The recalls started from 2014 to 2026. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

9 events, newest first.

FDA enforcement events of ARJOHUNTLEIGH POLSKA Sp. z.o.o.
InitiatedProduct (first record)TypeClassRecordsStatus
10 Mar 2026Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 USDeviceClass II1Ongoing
29 Aug 2023Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modulesDeviceClass II2Ongoing
5 Apr 2022Sara Plus Active Floor LiftDeviceClass I1Terminated
10 Jun 2021Arjo 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 (model no. INDIJAA) beds manufactured without IndiGo modules assembled at the time of manufacturing and…DeviceClass II1Terminated
21 Jul 2020Bariatric 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.DeviceClass II1Terminated
22 Aug 2019Concerto & 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], BAB1103-01 [UDI: (01)05055982796163], BAB1107-01 [(01)05055982796187], BAB2000-01 [UDI:…DeviceClass II1Terminated
22 Oct 2018ARJOHUNTLEIGH 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 one patient during hospital stay and assists the caregiver with everyday patient handling routines,…DeviceClass II1Terminated
29 Jun 2016ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.DeviceClass II1Terminated
28 Jul 2014Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult residents on horizontal floors in hospitals, nursing homes or other health care facilitates. The Minstrel device aids in the lifting, transfer and lowering to safe position, of a patient. This is…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

ARJOHUNTLEIGH POLSKA Sp. z.o.o.: events for each product type
TypeEvents
Device9
ARJOHUNTLEIGH POLSKA Sp. z.o.o.: events in each class
ClassEvents
Class II8
Class I1
Share of the events of the firm in Class I
11%
Share of all events on the register in Class I
18%
Events with the status Ongoing
2

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of ARJOHUNTLEIGH POLSKA Sp. z.o.o., by the year that the recall started. The largest year is 2014, with 1 event.

Official channels

Cite this page

Recall Register. ARJOHUNTLEIGH POLSKA Sp. z.o.o.: FDA recalls. https://recallregister.com/firm/arjohuntleigh-polska-sp-z-o-o/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of ARJOHUNTLEIGH POLSKA Sp. z.o.o. have?
Class II: 8 events. Class I: 1 event. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of ARJOHUNTLEIGH POLSKA Sp. z.o.o.?
FDA event 98542, which the firm started on 10 Mar 2026. The first product in the record is: Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
How many FDA recalls of ARJOHUNTLEIGH POLSKA Sp. z.o.o. have the status Ongoing?
2 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.