Food, drugs, devices › ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Device recall: Sara Plus Active Floor Lift

FDA enforcement event 89960 · Class I · initiated 5 Apr 2022 · status Terminated · terminated 5 Sep 2024

DeviceVoluntary: Firm initiated1 product record

FDA enforcement event 89960 is a device recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o. of Komorniki, initiated 5 Apr 2022 and classified Class I, with 1 product record.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 8% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Terminated, terminated 5 Sep 2024. Initiation: voluntary: firm initiated. ARJOHUNTLEIGH POLSKA Sp. z.o.o. has 9 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

ARJOHUNTLEIGH POLSKA Sp. z.o.o., Komorniki, Poland.

Reason for recall

"The device may emit smoke or ignite."

Distribution

"US Nationwide and Worldwide distribution"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1098-2022	Sara Plus Active Floor Lift	4449 devices	Class I	Terminated	1 Jun 2022

Context

8%of 2022 device events are Class I839 events that year

1product record in this eventfirm median: 1

9events on this register for the firm

Other enforcement events for ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Initiated	Product (first record)	Type	Class	Records
10 Mar 2026	Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US	Device	Class II	1
29 Aug 2023	Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive	Device	Class II	2
10 Jun 2021	Arjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and Ind	Device	Class II	1
21 Jul 2020	Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care env	Device	Class II	1
22 Aug 2019	Concerto & Basic Shower Trolly, Model Numbers BAB1000-01 (UDI: (01)05055982788083), BAB1000CON6102 [(01)05056097364483],	Device	Class II	1
22 Oct 2018	ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling is a product intended	Device	Class II	1
29 Jun 2016	ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.	Device	Class II	1
28 Jul 2014	Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and transporting adult reside	Device	Class II	1

All 9 events for ARJOHUNTLEIGH POLSKA Sp. z.o.o.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The device may emit smoke or ignite."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide and Worldwide distribution"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 5 Sep 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.