CLASS I Device recall · Reported 1 Jun 2022 · FDA Enforcement Report
Sara Plus Active Floor Lift recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o
Arjohuntleigh Polska Sp. z.o.o is recalling Sara Plus Active Floor Lift, distributed nationwide in the US. The recall was initiated on 5 Apr 2022 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1098-2022
- FDA event ID
- 89960
- Recalling firm
- Arjohuntleigh Polska Sp. z.o.o, Komorniki
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 5 Apr 2022
- FDA classified
- 20 May 2022
- Reported
- 1 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 Apr 2022 | Recall initiated by company | |
| 20 May 2022 | Classified by FDA | +45 days |
| 1 Jun 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device may emit smoke or ignite.
Product as listed by the FDA
Sara Plus Active Floor Lift
Where it was distributed
US Nationwide and Worldwide distribution
Questions about this recall
Why was it recalled?
The device may emit smoke or ignite.
Which lots are affected?
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
Where was it sold?
US Nationwide and Worldwide distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Arjohuntleigh Polska Sp. z.o.o
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Arjo Tenor mobile passive patient lift recalled | Arjohuntleigh Polska Sp. z.o.o | Device Malfunction | Nationwide |
| Device | CLASS II | Arjo medical beds recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o | Arjohuntleigh Polska Sp. z.o.o | Other | 7 states |
| Device | CLASS II | Arjo medical beds recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o | Arjohuntleigh Polska Sp. z.o.o | Other | 7 states |
| Device | CLASS II | Arjo Citadel beds originally assembled recalled | Arjohuntleigh Polska Sp. z.o.o | Other | Nationwide |
| Device | CLASS II | Bariatric Bed Frame System The Citadel Plus Bariatric Bed recalled | Arjohuntleigh Polska Sp. z.o.o | Other | Nationwide |
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