Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
FDA Device Recall #Z-1811-2026 — Class II — March 10, 2026
Recall Summary
| Recall Number | Z-1811-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 10, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | ARJOHUNTLEIGH POLSKA Sp. z.o.o. |
| Location | Komorniki, N/A |
| Product Type | Devices |
| Quantity | 119 units |
Product Description
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
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 Pattern
US Nationwide distribution.
Lot / Code Information
UDI-DI: 05055982787758 and 05055982787710 Serial Number: P0911221 P0909831 P0925191 P0907166 P0901255 P0906820 P0925431 P0912820 P0924568 P0910471 P0903999 P0914725 P0909539 P0910797 P0896659 P0911350 P0925190 P0914588 P0904321 P0905040 P0924559 P0913229 P0909537 P0923376 P0923377 P0911222 P0899348 P0909201 P0900805 P0912570 P0903592 P0912571 P0912573 P0914003 P0900806 P0910470 P0907737 P0907738 P0914004 P0908250 P0908429 P0914122 P0916220 P0912343 P0912821 P0924239 P0925203 P0925433 P0903476 P0912342 P0913326 P0904320 P0905039 P0897003 P0915180 P0898734 P0907165 P0907736 P0897841 P0903997 P0925432 P0896658 P0915498 P0914724 P0915163 P0913227 P0914118 P0908428 P0908768 P0914121 P0912572 P0915500 P0909200 P0911602 P0909202 P0912341 P0906821 P0899349 P0905354 P0905355 P0905356 P0905980 P0914726 P0908251 P0916221 P0910795 P0907167 P0907507 P0914589 P0897247 P0914587 P0903591 P0911601 P0903477 P0913228 P0910796 P0908430 P0903998 P0904319 P0904739 P0904740 P0899214 P0923462 P0905041 P0911603 P0907505 P0907506 P0898735 P0901254 P0912822 P0909830 P0910469 P0914586 P0899215 P0900415 P0897002 P0897248 P0914002 P0897842
Other Recalls from ARJOHUNTLEIGH POLSKA Sp. z.o.o.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0611-2024 | Class II | Arjo medical beds, Models Enterprise 5000X, Ent... | Aug 29, 2023 |
| Z-0612-2024 | Class II | Arjo medical beds, Models Enterprise 5000X, Ent... | Aug 29, 2023 |
| Z-1098-2022 | Class I | Sara Plus Active Floor Lift | Apr 5, 2022 |
| Z-2588-2021 | Class II | Arjo Citadel beds originally assembled with the... | Jun 10, 2021 |
| Z-2821-2020 | Class II | Bariatric Bed Frame System The Citadel Plus ... | Jul 21, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.