Agency classClass IIOur severity:High FDA (Devices)·Z-2524-2021·Announced 2021-09-29

C.R. Bard Foley Catheter Kit Recall: Packaging Sterility Defect

C.R. Bard is recalling Foley catheter kits due to packaging defects that may compromise the sterile barrier. No illnesses have been reported.

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: FDA Class II with a risk-of-harm hazard (packaging defect compromising sterile barrier, which could lead to infection), but no reported illnesses or injuries. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

C.R. Bard Inc is recalling Foley catheter kits sold under model Catalog A300318A, which includes the SureStep Foley Tray, Bardex I.C., Complete Care Drainage Bag, and StatLock Stabilization Device. The recall affects 350 units distributed nationwide in the United States.

The kits are being recalled due to potential packaging defects that may compromise the sterile barrier. A compromised sterile barrier could allow bacterial contamination of the catheter system.

No illnesses or injuries have been reported. If you have received or are using one of these kits, do not use the product. Contact C.R. Bard Inc to arrange return of the affected units. Healthcare facilities should check their inventory using lot number NGEVX106 and contact the manufacturer for replacement or further guidance.

The recalled product

Product: Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
Manufacturer: C.R. Bard Inc
Category: Medical Device — Urinary Catheter
Hazard: sterile-barrier-defect
contamination-risk
Affected units: 350

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 A300318A
Lot NGEVX106
UDI (01)00801741073748(17)201228(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