Arjo Medical Beds Recalled Due to Unintended Wheel Movement
Arjo medical beds with IndiGo Drive Assistance modules may have wheels that move unintentionally. This recall affects 83 units in seven U.S. states.
What this means for you
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: This is an FDA Class II recall of a medical device with no reported injuries or illnesses. The hazard of unintended bed wheel movement presents a potential risk but has not resulted in documented harm.
Plain-English summary
Arjo medical beds in Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X, and Citadel, assembled with or retrofitted with IndiGo Drive Assistance modules, are the subject of this Class II recall due to unintended movement of the bed wheels.
The recall affects 83 units that were distributed to Tennessee, California, New York, Illinois, Nevada, Pennsylvania, and South Dakota. The affected medical device identifier is UDI/DI 0505609734548.
Users and healthcare facilities should immediately cease use of any bed matching the recalled models and serial numbers. Contact ARJOHUNTLEIGH POLSKA or the FDA for further instructions on replacement or repair.
The recalled product
- Product
- Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules
- Manufacturer
- ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- Category
- Medical Device — Hospital Bed
- Hazard
- unintended-movement
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)
- UDI/DI 0505609734548
- serial numbers: P0504690
- P0504691
- P0510813
- P0512547
- P0512548
- P0515453
- P0515454
- P0515455
- P0515456
- P0515457
- P0516242
- P0517649
- P0517650
- P0517651
- P0517652
- P0517653
- P0517654
- P0517655
- P0517656
Distribution
Distributed in 7 states:
- CA
- IL
- NV
- NY
- PA
- SD
- TN
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27