Food, drugs, devices › ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Device recall: Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
FDA enforcement event 98542 is a device recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o. of Komorniki, N/A, initiated 10 Mar 2026 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. 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, N/A, Poland.
Reason for recall
"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."
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1811-2026 | Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US | 119 units | Class II | Ongoing | 22 Apr 2026 |
Context
Other enforcement events for ARJOHUNTLEIGH POLSKA Sp. z.o.o.
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: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.