Z-1098-2022Class I

Sara Plus Active Floor Lift

Name: Z-1098-2022 Sara Plus Active Floor Lift
Creator: ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Published: 2022-04-05
License: https://open.fda.gov/license/

ArjoHuntleigh Polska Sp. zo.o. / initiated 2022-04-05 / Terminated / root cause: design

FDA source

ARJOHUNTLEIGH POLSKA Sp. z.o.o. began a recall of Sara Plus Active Floor Lift on 2022-04-05. FDA classified it as Class I and gives the reason as "The device may emit smoke or ignite". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1098-2022
Classification: Class I
Status: Terminated
Initiated: 2022-04-05
Posted: 2022-05-21
Terminated: 2024-09-05
Recalling firm: ArjoHuntleigh Polska Sp. zo.o.
Product: Sara Plus Active Floor Lift
Product code: FSA Lift, Patient, Non-Ac-Powered
Reason for recall: The device may emit smoke or ignite.
Root cause tag: design
FDA root cause: Device Design
Action: A customer letter was sent to consignees on 04/08/2022. The customer are asked to acknowledge the notification, complete and sign off an enclosed Customer Response Form and return it to the local Arjo office (address indicated in the notification). The notification contains the list of precautionary measures to be taken by caregivers in order to minimize the likelihood of the failure until their lifts are corrected by Arjo. The device correction (including PCB upgrade and cover replacement) is to be performed by Arjo personnel, free of charge.
Quantity in commerce: 4449 devices
Distribution: US Nationwide and Worldwide distribution
Product codes and lots: Model Numbers: HEP0001, HEP0001-AU, HEP0001-BR, HEP0001-CN, HEP0001-JP, HEP0001-UK, HEP0001-US, HEP1001, HEP1001-AU, HEP1001CON4869, HEP1001-US, HEP2001, HEP2001-BR, HEP2001-CN, HEP2001-UK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1098-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1098-2022	Class I	Terminated	Voluntary: Firm initiated	2022-06-01	2022-05-20

Product code FSA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)