CLASS II Device recall · Reported 26 Aug 2020 · FDA Enforcement Report
Bariatric Bed Frame System The Citadel Plus Bariatric Bed recalled
Arjohuntleigh Polska Sp. z.o.o is recalling Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for, distributed nationwide in the US. The recall was initiated on 21 Jul 2020 and the FDA has classified it as Class II.
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-2821-2020
- FDA event ID
- 86065
- Recalling firm
- Arjohuntleigh Polska Sp. z.o.o, Komorniki, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jul 2020
- FDA classified
- 18 Aug 2020
- Reported
- 26 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Jul 2020 | Recall initiated by company | |
| 18 Aug 2020 | Classified by FDA | +28 days |
| 26 Aug 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Modular Junction Box (MJB) cables can melt and affect the bed functionality.
Product as listed by the FDA
Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
Where it was distributed
Worldwide distribution: US (nationwide) to states of:: FL, KS, LA and countries of:: Australia, Brazil, Canada, France and Germany.
Questions about this recall
Why was it recalled?
Modular Junction Box (MJB) cables can melt and affect the bed functionality.
Which lots are affected?
Serial number range: P0597830 to P0610470 Model numbers: FXX21A4A4AKFBB, FXX21A4D3AMFBA, FXX21C4B1AAABB, FXX21C4B4ABQBA, FXX21A4C4ACGBB, FXX21A4A1ABUBA, FXX21A6C2ABPBB, FXX21C4B1AAABA, FX811B3B4AMABB, FXX21C4D4AKBBB, FX611A2B2ALVBB
Where was it sold?
Worldwide distribution: US (nationwide) to states of:: FL, KS, LA and countries of:: Australia, Brazil, Canada, France and Germany.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 I | Sara Plus Active Floor Lift recalled by ARJOHUNTLEIGH POLSKA Sp. z.o.o | Arjohuntleigh Polska Sp. z.o.o | Other | Nationwide |
| Device | CLASS II | Arjo Citadel beds originally assembled recalled | Arjohuntleigh Polska Sp. z.o.o | Other | Nationwide |
Other Other Medical Devices recalls
All 13,929| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Rapicide PA Part A High-Level Disinfectant recalled by Steris | Steris | Other | Nationwide |
| Device | CLASS II | NeuroStar Advanced Therapy System recalled by Neuronetics | Neuronetics | Other | Nationwide |
| Device | CLASS II | TS Misc. Instruments Tray, Triathlon recalled by Howmedica Osteonics | Howmedica Osteonics | Sterility | NJ |
| Device | CLASS II | BD Phoenix Panel Nmic recalled by Becton Dickinson | Becton Dickinson | Device Malfunction | Nationwide |
| Device | CLASS II | BD Phoenix Panel Nmic recalled by Becton Dickinson | Becton Dickinson | Device Malfunction | Nationwide |