C.R. Bard Foley Catheter Tray recalled for potential packaging defects
C.R. Bard Inc is recalling approximately 29,890 units of Foley catheter trays due to potential packaging defects that may compromise the sterile barrier. No illnesses or injuries 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 recall with no reported illnesses or injuries. The hazard—potential packaging defects affecting the sterile barrier on an invasive medical device—represents a risk-of-harm product, meeting the rubric criterion for High severity.
Plain-English summary
C.R. Bard Inc is recalling Catalog A902916, a Foley catheter tray that includes SureStep Foley Tray, Lubricath, Urine Meter, and StatLock Stabilization Device. Approximately 29,890 units were distributed nationwide.
The FDA identified potential packaging defects that may impact the sterile barrier. No illnesses or injuries have been reported.
The affected product is used in healthcare settings. Individuals who have received these products should identify whether they have affected units by checking the lot numbers listed in the recall notice.
Consumers and healthcare providers with affected units should contact C.R. Bard Inc for information about replacement or next steps.
The recalled product
- Product
- Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
- Manufacturer
- C.R. Bard Inc
- Affected units
- 29,890
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 (8)
- Catalog A902916
- Lots: NGFR3115
- UDI (01)00801741074073(17)251228(10)
- NGFR3278
- NGFR3279
- NGFS1308
- NGFS1309
- and NGFS1366
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
- SevereSI-BONE iFuse TORQ Implant System Recalled for Sterility Assurance Issues
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
- LowC.R. Bard Recalls SureStep Urine Collection System for Labeling Issues
FDA (Devices) · 2016-08-10
- ModerateC.R. Bard Recalls SureStep Foley Tray Systems Due to Residue
FDA (Devices) · 2020-05-20
- HighC.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- HighC.R. Bard Recalls Medical Devices Containing Latex Catheters
FDA (Devices) · 2017-01-18
- ModerateBard Medical Recalls SureStep Foley Tray System Due to Leakage Risk
FDA (Devices) · 2019-02-13