Arjo Tenor mobile passive patient lift
Medical device recall Z-1811-2026. Published in FDA’s Enforcement Report on Apr 22, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 22, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 119 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
119 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,127 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 10, 2026.
- FDA classified it on Apr 10, 2026.
- FDA’s Enforcement Report published it on Apr 22, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- ARJOHUNTLEIGH POLSKA Sp. z.o.o., of Komorniki, Poland.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.