Agency classClass IIOur severity:High FDA (Devices)·Z-2533-2021·Announced 2021-09-29

Foley Catheter Tray Packaging Defect Poses Sterile Barrier Risk

C.R. Bard Inc is recalling a Foley catheter tray due to potential packaging defects that may compromise the sterile barrier. Approximately 1,710 units were 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: FDA Class II medical device recall involving a risk-of-harm product (sterile barrier defect could enable contamination). No illnesses or injuries are reported. Per the rubric, this qualifies as High (3) severity—a risk-of-harm product where injury has not yet been reported.

Plain-English summary

C.R. Bard Inc is recalling Catalog A897514 SureStep Foley Trays with SureStep Silicone Drainage Bags and StatLock Stabilization Devices. The FDA has classified this as a Class II recall. According to the recall notice, there is potential for packaging defects that may impact the sterile barrier on these medical devices.

The recall affects approximately 1,710 units that were distributed nationwide in the United States. The specific lot number involved is NGFR2808, with UDI (01)00801741104510(17)201228(10).

Patients and healthcare providers who have received these devices are advised to stop using affected units and contact C.R. Bard Inc for instructions on return or replacement.

The recalled product

Product: Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device
Manufacturer: C.R. Bard Inc
Category: Medical Device — Urinary Catheter Drainage
Hazard: sterile-barrier-defect
packaging-defect
Affected units: 1,710

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 A897514
Lot NGFR2808
UDI (01)00801741104510(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