Key facts
| Recalling firm | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US |
| Classification | Class II |
| Recall number | Z-1811-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| 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. |
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is ARJOHUNTLEIGH POLSKA Sp. z.o.o. and the affected product is described in FDA's record as: Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US. FDA's stated reason for the recall is: 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.. The recall is tracked under FDA recall number Z-1811-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US -- and the recall number Z-1811-2026. If it matches, stop using or distributing it and contact ARJOHUNTLEIGH POLSKA Sp. z.o.o. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
ARJOHUNTLEIGH POLSKA Sp. z.o.o.’s FDA history
Argus HQ has recorded 1 total FDA action tied to ARJOHUNTLEIGH POLSKA Sp. z.o.o.: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What was recalled and why?
- ARJOHUNTLEIGH POLSKA Sp. z.o.o. recalled Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US. FDA's record states 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.. The recall is logged under FDA recall number Z-1811-2026.
- How serious is this recall?
- FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
- What should someone who has this product do?
- Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US) and recall number Z-1811-2026, then follow ARJOHUNTLEIGH POLSKA Sp. z.o.o.'s recall instructions.
- Has ARJOHUNTLEIGH POLSKA Sp. z.o.o. had other FDA recalls or enforcement actions?
- This is the only FDA action Argus HQ has on file for ARJOHUNTLEIGH POLSKA Sp. z.o.o. so far. Argus ingests new FDA enforcement records daily.
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Related enforcement actions
Full FDA history for ARJOHUNTLEIGH POLSKA Sp. z.o.o.Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Class II Recall: Arjo Tenor mobile passive patient lift, Model Numbers… by ARJOHUNTLEIGH POLSKA Sp. z.o.o. — Recall Details. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-arjohuntleigh-polska-sp-z-o-o-z-1811-2026
"FDA Class II Recall: Arjo Tenor mobile passive patient lift, Model Numbers… by ARJOHUNTLEIGH POLSKA Sp. z.o.o. — Recall Details." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-arjohuntleigh-polska-sp-z-o-o-z-1811-2026.
Argus HQ Research. "FDA Class II Recall: Arjo Tenor mobile passive patient lift, Model Numbers… by ARJOHUNTLEIGH POLSKA Sp. z.o.o. — Recall Details." Digital Empire Holdings LLC. Accessed August 29, 2026. https://argushq.ai/recall/fda-recall-arjohuntleigh-polska-sp-z-o-o-z-1811-2026.
@misc{argushq_argushq_ai_recall_fda_recall_arjohuntleigh_polska_sp_z_o_o_z_1811_2026_2026,
title = {FDA Class II Recall: Arjo Tenor mobile passive patient lift, Model Numbers… by ARJOHUNTLEIGH POLSKA Sp. z.o.o. — Recall Details},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/fda-recall-arjohuntleigh-polska-sp-z-o-o-z-1811-2026},
note = {Accessed: August 29, 2026}
}Source: FDA.gov — Recalls ↗

