The Recall Desk
HighFDA (Devices)·Z-2462-2025·Announced 2025-09-03

Foley Catheter Lumen Obstruction Recall — Potential Urinary Drainage Failure

Bardex Foley catheters manufactured by C.R. Bard may develop obstructed lumens that prevent urine drainage, potentially causing kidney injury and pain. The recall affects 175,158 units distributed across specific U.S. states and Japan.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall for a functional defect (lumen obstruction) that poses risk of serious harm including acute kidney injury and obstructive uropathy. No hospitalization or injury reports are mentioned in the recall notice, placing this at High rather than Severe.

Plain-English summary

C.R. Bard is recalling Bardex Lubri-Sil I.C. 400-series Temperature Sensing Foley catheters and related complete-care tray systems (175,158 units) due to a potential lumen obstruction defect.

The obstruction may prevent proper bladder drainage, resulting in urine retention. Potential complications include abdominal or pelvic pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury, and hydronephrosis.

The affected devices were distributed nationwide in Iowa, Pennsylvania, Arkansas, Oregon, Minnesota, Indiana, West Virginia, Oklahoma, Alabama, Maryland, Hawaii, Georgia, Arizona, Massachusetts, Florida, California, and internationally in Japan. The recall encompasses multiple product variants and lot numbers with expiration dates through 2027.

The recalled product

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
Manufacturer
C.R. Bard Inc
Category
Medical Device — Urinary Catheters
Hazard
  • obstructed-lumen
  • drainage-failure
  • kidney-injury-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category