C.R. Bard Foley Catheter Trays Recalled for Packaging Defects
C.R. Bard is recalling 420 units of Foley catheter care trays 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 FDA Class II medical device has potential packaging defects affecting the sterile barrier. Compromised sterile barriers on urinary catheter equipment represent a risk-of-harm scenario. No illnesses or injuries have been reported, which per the rubric places this at the High severity level.
Plain-English summary
C.R. Bard Inc is recalling Catalog A303318A SureStep Foley Trays with Bardex I.C. catheters, Complete Care urine meters, and StatLock stabilization devices. The affected lot number is NGEVX105, and 420 units were distributed nationwide.
The recall was initiated due to potential packaging defects that may impact the sterile barrier of these medical devices. Consumers with affected products should contact C.R. Bard for further instructions.
The recalled product
- Product
- Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
- Manufacturer
- C.R. Bard Inc
- Affected units
- 420
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 A303318A
- Lot NGEVX105
- UDI (01)00801741073809(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 →Related recalls
Same manufacturer · C.R. Bard Inc
See all →- HighC.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- HighC.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- ModerateC.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- HighC.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- HighC.R. Bard Recalls SureStep Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
Same hazard · packaging defect
See all →- High
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FDA (Devices) · 2026-10-21
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
Similar recalls
- HighC.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- HighC.R. Bard Recalls Medical Devices Containing Latex Catheters
FDA (Devices) · 2017-01-18
- LowC.R. Bard Recalls SureStep Urine Collection System for Labeling Issues
FDA (Devices) · 2016-08-10
- HighC.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- HighBard Foley Catheter Trays Recalled for Temperature Display Malfunction
FDA (Devices) · 2024-06-26
- ModerateBard SureStep Foley Tray System Recalled for Potential Sample Port Leaks
FDA (Devices) · 2019-02-13