Bard Fluoro-4 Silicone Ureteral Stent — Class II medical device recall Z-0403-2017
Terminated recall by C.R. Bard, Inc., reported 2016-11-23, distributed nationwide. Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presenc
| Recall number | Z-0403-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard, Inc., Covington, GA, United States |
| Recall initiated | 2016-10-13 |
| Classified | 2016-11-14 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2022-02-10 |
| Distributed | Nationwide (US) |
| Quantity | 75,089 units |
| Reason classes | labeling |
Product
Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4", Silicone Ureteral Coil Stent; Bard¿ Silicone Uretera l Coil Stent with Figure Four, End, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
Reason for recall
Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
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-0403-2017. 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.