The Recall Desk
ModerateFDA (Devices)·Z-2076-2025·Announced 2025-07-09

Bard Urologist's Trays recalled for incorrect catheter size labeling

C.R. Bard is recalling Bard Urologist's Trays (REF 123400) because packaging may contain incorrect French catheter sizes. Affected units were distributed nationwide in the US and Canada.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II medical device recall for packaging/labeling defect (incorrect French catheter size). No illnesses or injuries have been reported. This is a labeling error with potential for user selection of wrong size, consistent with FDA's characterization as a Class II defect.

Plain-English summary

C.R. Bard Inc is recalling Bard Urologist's Trays (REF 123400) for the obstructed urethra. The recall affects 63 units due to packaging that may contain incorrect French size information.

Incorrect catheter sizing on packaging could lead a healthcare provider or user to select an inappropriate catheter size if they rely on the package labeling.

The affected trays were distributed nationwide across the United States and in Canada. The lot number is NGJX2513 (UDI: 00801741000294).

Affected customers should verify the actual catheter size in the tray against product documentation rather than relying solely on package labeling.

The recalled product

Product
REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
Manufacturer
C.R. Bard Inc
Category
Medical Device — Urology / Catheter
Hazard
  • size-mislabeling

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 (1)

  • Lot # NGJX2513/UDI: 00801741000294

Distribution

Distributed nationwide across the United States.

Related recalls

Same category