Severe FDA (Devices)·Z-1098-2022·Announced 2022-06-01

Sara Plus Active Floor Lift Recalled for Smoke and Ignition Risk

The FDA is recalling approximately 4,449 Sara Plus Active Floor Lift devices due to a fire hazard. The devices may emit smoke or ignite, posing a risk to users and staff.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I medical device recall. The classification mandates a minimum severity score of 4. While no injuries or deaths are reported in the source text, the fire hazard from potential smoke emission and ignition in a patient mobility device presents serious risk.

Plain-English summary

The U.S. Food and Drug Administration is recalling the Sara Plus Active Floor Lift manufactured by ARJOHUNTLEIGH POLSKA Sp. z.o.o. Approximately 4,449 devices are affected, with distribution nationwide in the United States and worldwide.

The floor lift may emit smoke or ignite, creating a fire hazard to patients and users in healthcare facilities and homes.

Consumers and healthcare facilities using this device should stop use immediately and contact the manufacturer for instructions regarding remedy or proper device return.

The recalled product

Product: Sara Plus Active Floor Lift
Manufacturer: ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Category: Medical Device — Patient Lift / Mobility Equipment
Hazard: fire
smoke
Affected units: 4,449

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 (15)

Model Numbers: HEP0001
HEP0001-AU
HEP0001-BR
HEP0001-CN
HEP0001-JP
HEP0001-UK
HEP0001-US
HEP1001
HEP1001-AU
HEP1001CON4869
HEP1001-US
HEP2001
HEP2001-BR
HEP2001-CN
HEP2001-UK

Distribution

Distributed nationwide across the United States.

Same manufacturer · ARJOHUNTLEIGH POLSKA Sp. z.o.o.

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Same hazard · fire