Agency classClass IIOur severity:High FDA (Devices)·Z-2527-2021·Announced 2021-09-29

C.R. Bard SureStep Foley Catheter Tray Sterile Barrier Defect Recall

C.R. Bard is recalling 5,950 SureStep Foley Tray kits nationwide due to potential packaging defects that may impact the sterile barrier.

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 medical device recall involving potential sterile barrier defects on a critical medical device (Foley catheter tray). Although no illnesses or injuries are reported in the source text and the hazard is stated as potential rather than confirmed, this qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

C.R. Bard Inc. is recalling 5,950 SureStep Foley Tray kits (catalog A319416AM) distributed nationwide. The product includes integrated components: Bardex I.C., Complete Care, Urine Meter, Temperature Sensing, and StatLock Stabilization Device. Affected lot numbers are NGEVX107 (expiring 08/31/2022), NGFR3116 (expiring 02/28/2023), and NGFS1808 (expiring 02/28/2023).

The recall was initiated due to potential packaging defects that may impact the product's sterile barrier. The FDA has classified this as a Class II recall.

Healthcare facilities and medical providers across the United States who have received affected units should be aware of this recall.

The recalled product

Product: Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
Manufacturer: C.R. Bard Inc
Category: Medical Device — Urinary Catheter / Drainage System
Hazard: packaging-defect
sterile-barrier-defect
Affected units: 5,950

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 (5)

Catalog A319416AM
Lots NGEVX107 (exp. 08/31/2022)
UDI (01)00801741073861(17)201220(10)
NGFR3116 (exp. 02/28/2023)
and NGFS1808 (02/28/2023) UDI (01)00801741073861(17)201220(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 · packaging defect