Arjohuntleigh Polska SP Z.O.O.
United KingdomFDA applicant, unverified FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 113 ongoing
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Arjohuntleigh Polska SP Z.O.O. makes
The company manufactures continuous passive motion (CPM) devices, including the FLOWTRON ACS800 pump system for joint rehabilitation and sterile foot garments designed to reduce swelling and improve circulation. These products are used in postoperative recovery and physical therapy settings to enhance mobility and tissue healing.
The portfolio consists of Class II medical devices, authorised through the FDA’s 510(k) clearance process. The company is based in the United States and its products are listed under this regulatory framework.
Catalogue
Flowtron ACS800 Pump And Tri Pulse Garments Ref K133119
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 11 recalls initiated by Arjohuntleigh Polska SP Z.O.O., the earliest on 2014-06-10 and the most recent on 2026-03-10. By recorded status: 3 ongoing and 8 terminated. The reasons filed fall into these groups: electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 1
- 2019 1
- 2020 1
- 2021 1
- 2022 1
- 2023 2
- 2024 0
- 2025 0
- 2026 1
2026
- 10 Mar 2026 Z-1811-2026 Class II Ongoing 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.
2023
- 29 Aug 2023 Z-0611-2024 Class II Ongoing Unintended movement of bed wheels
- 29 Aug 2023 Z-0612-2024 Class II Ongoing Unintended movement of bed wheels
2022
- 5 Apr 2022 Z-1098-2022 Class I Terminated The device may emit smoke or ignite.
2021
- 10 Jun 2021 Z-2588-2021 Class II Terminated 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.
2020
- 21 Jul 2020 Z-2821-2020 Class II Terminated Modular Junction Box (MJB) cables can melt and affect the bed functionality.
Full distribution text
- 21 Jul 2020 Z-2821-2020 Class II Terminated Modular Junction Box (MJB) cables can melt and affect the bed functionality.
2019
- 22 Aug 2019 Z-1452-2020 Class II Terminated 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.
Full distribution text
- 22 Aug 2019 Z-1452-2020 Class II Terminated 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.
2018
- 22 Oct 2018 Z-0589-2019 Class II Terminated 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.
Full distribution text
- 22 Oct 2018 Z-0589-2019 Class II Terminated 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.
2016
- 29 Jun 2016 Z-2718-2016 Class II Terminated 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 during internal device testing. To date, there have been no adverse events or customer complaints related to the tipping phenomenon. The tipping hazard may occur when fully loaded Sara Combilizer in "stretcher mode" is lifted to the highest position (approximately 984 mm = 38 3/4") and tilted backwards to the angle of 25 degrees-28 degrees. Although such scenario has been defined as highly unlikely to occur during use with patients, as a commitment to quality, ArjoHuntleigh is providing customers with information on action needed. The Sara Combilizer may stay in use until the upgrade will be performed, on the condition
that the tilt angle in the device ''stretcher mode" will be no greater than minus 15 degrees and the device is not loaded over 330 lbs (150 kg).
Full distribution text
- 29 Jun 2016 Z-2718-2016 Class II Terminated 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 during internal device testing. To date, there have been no adverse events or customer complaints related to the tipping phenomenon. The tipping hazard may occur when fully loaded Sara Combilizer in "stretcher mode" is lifted to the highest position (approximately 984 mm = 38 3/4") and tilted backwards to the angle of 25 degrees-28 degrees. Although such scenario has been defined as highly unlikely to occur during use with patients, as a commitment to quality, ArjoHuntleigh is providing customers with information on action needed. The Sara Combilizer may stay in use until the upgrade will be performed, on the condition
that the tilt angle in the device ''stretcher mode" will be no greater than minus 15 degrees and the device is not loaded over 330 lbs (150 kg).
2014
- 28 Jul 2014 Z-2693-2014 Class II Terminated 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 serviced, or when they receive a sharp blow during or outside of use, it is possible the bolt holding the spreader bar to the scale could unscrew during subsequent use. As a result, the sp
Show all 11 recalls
2014
- 10 Jun 2014 Z-2652-2014 Class II Terminated ArjoHuntleigh received reports where the Tenor Lift without Scale (spreader bar) bolt broke during use. There is a remote risk concerning the breakage of the spreader bar bolt connection, part # TEN.018. During use, the bolt is subjected to mechanical forces, which may lead to breakage.
Full distribution text
- 10 Jun 2014 Z-2652-2014 Class II Terminated ArjoHuntleigh received reports where the Tenor Lift without Scale (spreader bar) bolt broke during use. There is a remote risk concerning the breakage of the spreader bar bolt connection, part # TEN.018. During use, the bolt is subjected to mechanical forces, which may lead to breakage.
FDA establishments
- ArjoHuntleigh Polska Sp. z o.o. Poznan Wielkopolskie · PL FEI 3007420694
Frequently asked questions
How many devices does Arjohuntleigh Polska SP Z.O.O. have in the registry?
The registry currently lists 2 devices for Arjohuntleigh Polska SP Z.O.O.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Arjohuntleigh Polska SP Z.O.O.'s devices?
Among its 2 most recently registered devices, Arjohuntleigh Polska SP Z.O.O. has devices listed in FDA 510(k) (2 devices).
What risk classes do Arjohuntleigh Polska SP Z.O.O.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Arjohuntleigh Polska SP Z.O.O.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Arjohuntleigh Polska SP Z.O.O.?
FDA recall records list 11 recalls initiated by Arjohuntleigh Polska SP Z.O.O., the most recent initiated on 10 Mar 2026. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Arjohuntleigh Polska SP Z.O.O. in the registry?
The most recently registered devices listed for Arjohuntleigh Polska SP Z.O.O. include FLOWTRON ACS800 PUMP AND TRI PULSE GARMENTS and FLOWTRON FOOT GARMENT-REGULAR-STERILE FLOWTRON FOOT GARMENT-LARGE-STERILE.
Which FDA establishments are linked to Arjohuntleigh Polska SP Z.O.O.?
1 FDA establishment is linked to Arjohuntleigh Polska SP Z.O.O. in the registry; they are listed on the company page.