FDA Device recall Z-2462-2025
Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314
- FDA Device
- Class II
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class II recall of Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314 by C R Bard, citing 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 dysfunct….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2462-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-06-18 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | C R Bard |
| Distribution | US |
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
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.
Identifiers
| code_info | Catalog/UDI-DI/Lot(Expiration): 119314/00801741039843, 10801741039840/NGJS3588(31/03/2029), NGKQ2500(21/12/2029), NGKQ0…Catalog/UDI-DI/Lot(Expiration): 119314/00801741039843, 10801741039840/NGJS3588(31/03/2029), NGKQ2500(21/12/2029), NGKQ0170(30/11/2029), NGJW2499(31/08/2029), NGJT1284 (31/03/2029), NGKQ2492(31/12/2029), NGKP3152(31/12/2029), NGJX0215(31/07/2029). A319514A/00801741100321, 10801741100328/NGJN0498(31/01/2026), NGJW3127(30/04/2027) 29000J14/21200BZY00110000/MYJX0683(28/05/2027), MYJP0751(28/02/2027), MYJR1984(28/04/2027), MYJQ0070(28/04/2027), MYJS6278(28/04/2027), MYJR3026(28/04/2027), MYJT3766(28/04/2027), MYJY6197(28/06/2027), MYJX2833(28/06/2027), MYJQ4022(28/04/2027), MYJT3764(28/04/2027), MYJZ0962(28/06/2027), MYJS4679(28/04/2027), MYJX0686(28/06/2027), MYJV4359(28/03/2027), MYJS3597(28/04/2027), MYJW1900(28/04/2027), MYJT3765(28/04/2027), MYJY1245(28/06/2027), MYJY1242(28/06/2027), MYJY1248(28/06/2027). 29030J14/21200BZY00110000/MYJX2846(28/06/2027), MYJP2013(28/02/2027), MYJT1017(28/04/2027), MYJW1906(28/04/2027), MYJT4535(28/07/2027), MYJP4407(28/04/2027), MYJS1895(28/04/2027) |
|---|
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-2462-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.