BARDEX I — Class II medical device recall Z-1357-2016
Terminated recall by C.R. Bard, Inc., reported 2016-04-20, distributed nationwide. Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
| Recall number | Z-1357-2016 |
|---|---|
| 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 | 2015-12-18 |
| Classified | 2016-04-08 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2016-06-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 1,428,000 units |
| Reason classes | labeling |
| Model numbers | 0165I108, 065SI10 |
Product
BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
Reason for recall
Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
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-1357-2016. 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.