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

Foley catheters recalled because obstructed lumen may prevent bladder drainage

Bardex Lubri-Sil I.C. Foley catheters and related tray systems are recalled because the catheter may have an obstructed lumen, which may prevent the bladder from draining. 175,158 units are affected.

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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes potential harms including acute kidney injury and reports no injuries.

Plain-English summary

Bardex Lubri-Sil I.C. 400-series temperature sensing silver/hydrogel coated all-silicone Foley catheters with 5cc balloon, REF 119314, are being recalled, along with the SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF A319514A, and Bard Silver Lubri-Sil Foley trays. Affected catalog, UDI-DI and lot numbers with expiry dates are listed in the recall notice, including lot NGJS3588. The recall covers 175,158 units distributed in the United States and internationally.

The Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder of urine. The manufacturer states the consequences may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis. The FDA classified the action as Class II.

Hospitals and clinics holding affected lots should quarantine them and follow the manufacturer's instructions for return or replacement.

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 — Urological Catheter
Hazard
Affected units
175,158

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.

The notice also names 16 states specifically:

Related recalls

Same manufacturer · C.R. Bard Inc

See all →