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

Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Cathe

Pending LLM rewrite. Source: FDA_DEVICE Z-2462-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

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 — Devices

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