SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray — Class II medical device recall Z-2591-2025
Ongoing recall by C.R. Bard Inc, reported 2025-09-24, distributed nationwide. Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)N
| Recall number | Z-2591-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | C.R. Bard Inc, Covington, GA, United States |
| Recall initiated | 2025-07-17 |
| Classified | 2025-09-18 |
| Reported by FDA | 2025-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 3,670 |
| Lot numbers | NGJX4320 |
| Model numbers | A942216 |
Product
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
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 antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
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-2591-2025. 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.