Agency classClass IIOur severity:High FDA (Devices)·Z-2530-2021·Announced 2021-09-29

Foley Catheter Tray Recalled for Packaging Defects Affecting Sterile Barrier

C.R. Bard Inc is recalling SureStep Foley Catheter Trays due to potential packaging defects that may compromise the sterile barrier. The affected lot includes 1140 units distributed nationwide.

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: This is an FDA Class II recall involving a sterile medical device with potential packaging defects that could compromise the sterile barrier and create infection risk. No illnesses or injuries have been reported, consistent with the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

C.R. Bard Inc is recalling the SureStep Foley Tray (Catalog A800360, Bard Lubricath Foley Catheter Tray) due to potential packaging defects that may impact the sterile barrier. The recall affects 1140 units of Lot NGFR3570, distributed nationwide in the United States.

A compromised sterile barrier could allow contamination of the medical device, creating a risk of infection or other adverse health effects when used. Foley catheter trays are intended for use in urinary catheter insertion procedures.

Consumers who have this product should discontinue use and consult their healthcare provider or physician for guidance. Healthcare facilities should review their inventory for the recalled lot number and implement appropriate measures to ensure patient safety.

The recalled product

Product: Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Manufacturer: C.R. Bard Inc
Category: Medical Device — Catheter Tray
Hazard: sterile-barrier-defect
infection-risk
Affected units: 1,140

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 (3)

Catalog A800360
Lot NGFR3570
UDI (01)00801741073922(17)251228(10)

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 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 21 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
Moderate
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

Same hazard · sterile barrier defect