Cordis SABER PTA Balloon Dilation Catheter — Class II medical device recall Z-2235-2021
Terminated recall by Cordis Corporation, reported 2021-08-18, distributed nationwide. The balloon protective sheath may potentially be contaminated with a foreign material left over from the manuf
| Recall number | Z-2235-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2021-07-19 |
| Classified | 2021-08-09 |
| Reported by FDA | 2021-08-18 |
| Terminated | 2023-02-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, PL, PT |
| Quantity | 8 units |
| Reason classes | foreign material |
| Lot numbers | 82219442 |
| Model numbers | 48004010X |
Product
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Reason for recall
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
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-2235-2021. 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.