Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94722

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 09, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
C.R. Bard Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended for use in the drainage and/or collection and/or measurement of urine.

Z-2154-2024
Recall number
Z-2154-2024
Initiated
May 09, 2024
Classification
Class II
Status
Ongoing
Recalling firm
C.R. Bard Inc
Quantity
6,420 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.

Code information

SureStep Foley Tray System - Lot #NGHZ1757, exp. 31Jan2026, UDI-DI 00801741073861 (eaches); 10801741073868 (case). Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray, Lot #NGHX2932, exp. 31May2025, UDI-DI 00801741024450 (each); 10801741024457 (case).

Distribution pattern

Distribution was nationwide. There was no government/military/foreign distribution.