i — Class II medical device recall Z-0989-2017
Terminated recall by HEALTH ROBOTICS S.R.L., reported 2017-01-18. The firm has initiated a product correction due to a bag carousel motor error causing misalignment and resulti
| Recall number | Z-0989-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | HEALTH ROBOTICS S.R.L., Bolzano, Italy |
| Recall initiated | 2016-11-23 |
| Classified | 2017-01-10 |
| Reported by FDA | 2017-01-18 |
| Terminated | 2017-03-15 |
| Quantity | 121 systems |
| Reason classes | labeling |
Product
i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
Reason for recall
The firm has initiated a product correction due to a bag carousel motor error causing misalignment and resulting in a mislabeling of final IV bag preparations.
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-0989-2017. 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.