Agency classClass IIOur severity:High FDA (Devices)·Z-2521-2021·Announced 2021-09-29

C.R. Bard SureStep Foley Tray Recalled for Packaging Defect Risk

C.R. Bard is recalling SureStep Foley Tray units due to potential packaging defects that may compromise the sterile barrier. The recalled product was distributed nationwide in the United States.

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 a Class II recall involving a medical device where sterile barrier integrity is critical to patient safety. Although no illnesses have been reported, the potential for packaging defects to compromise sterility on an invasive medical device creates a risk-of-harm scenario.

Plain-English summary

C.R. Bard Inc is recalling 10,150 units of its SureStep Foley Tray (Catalog A119216M) due to potential packaging defects that may compromise the sterile barrier. The affected lot numbers are NGFR2561 and NGFS1312. These units were distributed nationwide across the United States.

The sterile barrier is essential for maintaining product sterility and preventing microbial contamination during storage, handling, and use of the catheter tray. Defective packaging could allow contamination to occur before the device is used, potentially creating a serious infection risk.

No illnesses or injuries have been reported to date in connection with this recall. Healthcare facilities and consumers should contact C.R. Bard Inc with any questions or to report adverse events.

The recalled product

Product: Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
Manufacturer: C.R. Bard Inc
Category: Medical Device — Catheter / Urological
Hazard: sterile-barrier-defect
contamination-risk
Affected units: 10,150

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 (4)

Catalog A119216M
Lots NGFR2561
UDI (01)00801741073687(17)201228(10) and NGFS1312
UDI (01)00801741073687(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