ArjoHuntleigh Recalls Tenor Mobile Passive Lifts Due to Bolt Breakage Risk
ArjoHuntleigh is recalling Tenor mobile passive lifts because the spreader bar bolt may break during use, posing a risk to patients and caregivers.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural component (bolt) that may break during use, posing a risk of harm to patients and caregivers, although no specific injuries are reported in the source text.
Plain-English summary
ArjoHuntleigh Polska Sp. z o.o. is recalling the Tenor mobile passive lift, model KHA1000-US. The recall involves 382 units worldwide, including 160 units in the United States. These devices are intended for lifting and transferring patients in healthcare facilities such as hospitals and nursing homes.
The recall was initiated after ArjoHuntleigh received reports that the spreader bar bolt (part # TEN.018) broke during use. The company identified a remote risk that the bolt connection may break due to mechanical forces applied during operation. This breakage could compromise the stability of the lift.
Healthcare facilities should stop using the affected Tenor lifts immediately. Users should check their device serial numbers against the list provided by the manufacturer to determine if their unit is affected. Affected units should be removed from service pending further instructions from ArjoHuntleigh.
The recalled product
- Product
- Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer in hospitals, nursing homes or other healthcare facilities. Transfers with the Tenor are made indoors in the patient's room, in communal areas or in a bathroom. Tenor is meant to…
- Manufacturer
- ARJOHUNTLEIGH POLSKA SP. ZO.O.
- Category
- Medical Device — Patient Lifts
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: KHA1000-US
- Serial Numbers: P0111930
- P0112213
- P0112214
- P0117472
- P0121496
- P0123586
- P0125147
- P0127106
- P0127347
- P0127348
- P0128923
- P0128924
- P0129153
- P0129154
- P0129369
- P0129370
- P0131041
- P0131526
- P0131527
Distribution
Distributed nationwide across the United States.
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