FDA Device recall Z-2591-2025
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
- FDA Device
- Class II
- ongoing
- Published 2025-09-24
On 2025-09-24 the FDA classified a Class II recall of SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216 by C R Bard, citing 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 silicon….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2591-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-17 |
| Published | 2025-09-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | C R Bard |
| Distribution | US |
Product
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
Reason
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
Identifiers
| code_info | Lot# NGJX4320 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2591-2025%22
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