Agency classClass IIOur severity:High FDA (Devices)·Z-2535-2021·Announced 2021-09-29

SureStep Foley Tray Recall: Packaging Defects May Compromise Sterile Barrier

C.R. Bard Inc is recalling SureStep Foley Trays (Catalog A902616) due to packaging defects that may compromise the sterile barrier. Affected 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: This is an FDA Class II recall for a potential sterile barrier defect in a medical device used for urinary drainage. However, the source text reports no actual illnesses, injuries, or deaths. Per the rubric, theoretical hazards to risk-of-harm products without reported injury score at most 3 (High).

Plain-English summary

C.R. Bard Inc is recalling SureStep Foley Trays (Catalog A902616, Lot NGFR3277) distributed nationwide. The recall affects 80 units of this urinary drainage product, which is used for bladder drainage management.

The FDA Class II recall is due to potential packaging defects that may impact the sterile barrier. A compromised sterile barrier could allow contamination of the product.

The affected lot can be identified by catalog number A902616 and lot number NGFR3277 (UDI: 00801741104633). Affected units were distributed nationwide in the United States.

Patients currently using any of the recalled product should discontinue use and contact C.R. Bard Inc or their healthcare provider. Healthcare providers should assess whether patients may have received any of the affected units and take appropriate action.

The recalled product

Product: Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter
Manufacturer: C.R. Bard Inc
Category: Medical Device — Urinary catheter system
Hazard: packaging-defect
sterile-barrier-defect
Affected units: 80

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 A902616
Lot NGFR3277
UDI (01)00801741104633(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 →

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C.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
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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