Drug recall
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
FDA recall event 97273 · Class II · C.R. Bard Inc
Key facts
| Event ID | 97273 |
|---|---|
| Recall numbers | Z-2589-2025, Z-2590-2025, Z-2591-2025 |
| Recalling firm | C.R. Bard Inc |
| Product type | Devices |
| Products | SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A, SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216, SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with… |
| Initiation date | Jul 17, 2025 |
| Report date | Sep 24, 2025 |
| City | Covington |
| State | GA |
| Country | United States |
| FEI number | 1018233 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: