Agency classClass IIOur severity:High FDA (Devices)·Z-2591-2025·Announced 2025-09-24

Lubri-Sil Foley trays recalled over inserts describing the wrong catheter material

SureStep Foley Tray Systems with Bard Lubri-Sil catheters, REF A942216 lot NGJX4320, are recalled because incorrect inserts may lead users to misidentify the catheter material or coating. 3,670 units are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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; a latex or coating mismatch that may cause infection or allergic reaction is a potential harm and no injuries are reported.

Plain-English summary

The SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF A942216, lot NGJX4320, is being recalled. The recall covers 3,670 units distributed across more than 15 states.

The Foley catheter trays have incorrect inserts. A user may believe the catheter is silicone when it is natural rubber latex; or natural rubber latex with an infection control coating when it is silicone hydrogel with an antimicrobial coating; or natural latex with infection control when it is silicone hydrogel coated without an antimicrobial coating. The manufacturer states this may cause infection and/or a local and/or systemic allergic reaction. The FDA classified the action as Class II.

Hospitals holding this lot should quarantine it and follow the manufacturer's instructions for return or replacement.

The recalled product

Product: SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
Manufacturer: C.R. Bard Inc
Category: Medical Device — Urological Catheter
Hazard: incorrect-insert
latex-mismatch
allergic-reaction-risk
class-ii
Affected units: 3,670

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# NGJX4320

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Part of a larger recall action

This product is one of 3 recalled by C.R. Bard Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · C.R. Bard Inc

See all →

High
C.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
High
C.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
High
C.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
High
C.R. Bard Recalls SureStep Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
Moderate
C.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16

Same hazard · incorrect insert