C.R. Bard Inc: 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

Recall number

Z-2462-2025

Recalling firm

C.R. Bard Inc

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

Status

Open, Classified

Initiated

2025-06-18

Posted

2025-08-28

Terminated

not on file

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.

Root cause

Process design

Action

On 6/18/2025, recall notices were mailed or emailed to Recall Coordinators, Directors of Nursing, Purchasing, Risk Management, and distributors who were informed the following: The affected product was distributed from 07 March 2024 to 14 May 2025. - If affected product is currently indwelling and draining urine appropriately, the catheter does not need to be removed. - For affected product currently not in use, quarantine, and dispose of unused product and source alternative product. - Share this notice with any users of the product within your facilities to ensure they are also aware of this Medical Device Recall (Correction). - If you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product. - Complete and return the attached Customer Response Form via Email BDRC26@bd.com Report any complaints experienced with the use of this product to the firm via the North American Regional Complaint Center: Phone: 1-844-8BD-LIFE (1-844-823-5433) say "Product Complaints" when prompted Mon-Fri 8:00am and 5:00pm CT, Email: productcomplaints@bd.com Firm's Medical Information Services: 1-800-555-7422, medical.information@bd.com

Quantity

175,158

Distribution

Worldwide - US Nationwide distribution in the states of IA, PA, AR, OR, MN, IN, WV, OK, AL, MD, HI, GA, AZ, MA, FL, CA and the countries of Japan.

Lot, serial or model codes

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), MYJW1904(28/04/2027), MYJV4102(28/03/2027), MYJX2836(28/05/2027), MYJZ4526(28/06/2027), MYJT3468(28/04/2027), MYJP2012(28/02/2027), MYJV4099(28/03/2027), MYJZ0964(28/06/2027), MYJQ0071(28/04/2027), MYJS6279(28/04/2027), MYJY4511(28/06/2027), MYJQ4024(28/04/2027), MYJZ0963(28/06/2027), MYJT1018(28/04/2027), MYJR3027(28/04/2027), MYJS3599(28/04/2027), MYJQ4023(28/04/2027), MYJR3083(28/04/2027), MYJY4512(28/06/2027), MYJQ0073(28/04/2027), MYJS1893(28/04/2027), MYJN2580(28/01/2027), MYJU2705(28/08/2027), MYJZ4527(28/06/2027), MYJS1894(28/04/2027), MYJV4103(28/03/2027), MYJR3059(28/04/2027), MYJU0772(28/08/2027), MYJV4101(28/03/2027), MYJY4513(28/06/2027), MYJQ0072(28/04/2027), MYJU3846(28/03/2027), MYJU3847(28/05/2027), MYJX2841(28/06/2027), MYJX2840(28/05/2027), MYJX2839(28/05/2027), MYJY4510(28/06/2027), MYJY4509(28/06/2027), MYJV4100(28/06/2027), MYJU3848(28/06/2027). 29000J14S/21200BZY00110000/MYJY1249(28/06/2027), MYJY0937(28/05/2027), MYJW1903(28/03/2027). 29030J14S/21200BZY00110000/MYJU0773(28/08/2027)

510(k) numbers

["K070582"]

PMA numbers

not on file

Product code

EZL

Firm FEI

1018233

Firm city

Covington

Firm state

GA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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