C.R. Bard Inc: Medical Device Recall in 2025 - (Recall #: Z-2462-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 18, 2025

Date Posted: September 3, 2025

Recall Number: Z-2462-2025

Event ID: 97041

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.

Status: Ongoing

Product Quantity: 175,158

Code Information:

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)

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated