Class 2 Device Recall Arjo Tenor Lift

• Date Initiated by Firm: March 10, 2026
• Date Posted: April 10, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1811-2026
• Recall Event ID: 98542
• Product Classification: Lift, patient, non-ac-powered - Product Code FSA
• Product: Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
• 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
• FEI Number: 3007420694
• Recalling Firm/ Manufacturer: ARJOHUNTLEIGH POLSKA Sp. z.o.o.; Ul. Ks. Piotra Wawrzyniaka 2; Komorniki Poland
• Manufacturer 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.
• FDA Determined Cause: Process control
• Action: An Urgent Medical Device Correction notification letter was sent to customers beginning 3/10/26. IMPORTANT: To mitigate the risk, all affected Tenor lifts must be removed from use immediately and should not be operated until the corrective action is completed. No additional user checks or temporary measures can reduce the risk. Arjo service personnel will carry out a required free of charge actuator replacement to restore the safe performance of the device. Solution to the issue: Arjo will implement a Field Safety Corrective Action consisting of a replacement of the affected actuator (TEN.107) with a fully safe component. This correction will permanently remove the risk and restore the actuator s ability to hold the load, thereby eliminating the identified risk of sudden, uncontrolled downward movement of the lifting arm. Until the actuator is replaced, the affected Tenor lifts must remain out of service and must not be used for patient handling, as no temporary measures can ensure safe operation. The device does not require destruction or return; it will be corrected on-site through actuator replacement. Next Steps: 1. Immediately remove all the affected Tenor lifts from service, keep them out of use until the corrective action is completed, and inform all relevant staff within your facility about this Field Safety Notice. 2. Complete and return the Customer Response Form to your local Arjo representative, including details of any affected devices that have been sold or transferred to another facility. 3. Ensure availability of all affected devices for the actuator replacement and designate a facility contact person; Arjo will contact this representative to schedule the corrective action visit. 4. Maintain awareness of this notice until the corrective action has been completed for all affected units. Please note: if your facility has sold or moved the Tenor Lift please include the new facility s information in the Customer Response Form. If you have any further
• Quantity in Commerce: 119 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.