Arjo medical beds — Class II medical device recall Z-0612-2024
Ongoing recall by ARJOHUNTLEIGH POLSKA Sp. z.o.o., reported 2024-01-03, distributed in CA, IL, NV, NY, PA, SD, TN. Unintended movement of bed wheels
| Recall number | Z-0612-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARJOHUNTLEIGH POLSKA Sp. z.o.o., Komorniki, Poland |
| Recall initiated | 2023-08-29 |
| Classified | 2023-12-22 |
| Reported by FDA | 2024-01-03 |
| Distributed | CA, IL, NV, NY, PA, SD, TN |
| Quantity | 846 units |
| Serial numbers | P0493376, P0493377, P0493378, P0493379, P0493380, P0493381, P0493382, P0493383, P0493384, P0493385, P0493386, P0493387, P0493388, P0493389, P0493390, P0493421, P0493422, P0493423, P0493424, P0493425, P0493426, P0493427, P0493428, P0493429, P0493430 and 475 more |
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
Reason for recall
Unintended movement of bed wheels
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0612-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.