Bardex Lubri-Sil I — Class II medical device recall Z-2462-2025
Ongoing recall by C.R. Bard Inc, reported 2025-09-03, distributed nationwide. Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine a
| Recall number | Z-2462-2025 |
|---|---|
| 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 | 2025-06-18 |
| Classified | 2025-08-28 |
| Reported by FDA | 2025-09-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 175,158 |
| UPC / GTIN / UDI-DI | 00801741039843, 00801741100321, 10801741039840, 10801741100328 |
| Lot numbers | 119314/00801741039843, A319514A/00801741100321, NGJT1284 |
| Model numbers | 119314, 29000J14, 29000J14S, 29030J14, 29030J14S, A319514A |
Product
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29000J14, 29030J14, 29000J14S; Bard Silver Lubri-Sil Foley Tray Temperature Sensing, Complete Care with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 14Fr, REF: 29030J14S
Reason for recall
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
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-2462-2025. 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.