Class II U.S. Food and Drug Administration

ARJOHUNTLEIGH POLSKA Sp. z.o.o. Arjo Tenor mobile passive patient lift recall: An internal component of the actuators in a certain production batch

Recall published 6 months ago

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 hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1811-2026
Published
April 22, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Product type
Medical devices
Units affected
119 units
Distribution
Nationwide
Made in
Poland
Lot / code info
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
UPC codes
05055982787758, 05055982787710

Products covered by this recall

Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 05055982787758
  • 05055982787710

Model or item number

On the rating label, the box or the instruction sheet.

  • KHA1000 US
  • KHA1010 US — UDI-DI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

ARJOHUNTLEIGH POLSKA Sp. z.o.o. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: ARJOHUNTLEIGH POLSKA Sp. z.o.o. — Ul. Ks. Piotra Wawrzyniaka 2, Komorniki

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was ARJOHUNTLEIGH POLSKA Sp. z.o.o. medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 05055982787758, 05055982787710; model number KHA1000 US, KHA1010 US — UDI-DI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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