C.R. Bard Foley Catheter Tray Recall Due to Packaging Defects
C.R. Bard Inc is recalling the SureStep Foley Tray (Lot NGEVX108) due to potential packaging defects that may affect the sterile barrier. The product was 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 recall of a risk-of-harm medical device with no reported illnesses or injuries. The hazard—packaging defects potentially compromising the sterile barrier—is theoretical and precautionary.
Plain-English summary
C.R. Bard Inc is recalling the SureStep Foley Tray (Catalog A943216), which includes a Lubricath urine meter and StatLock stabilization device, due to potential packaging defects. The recalled product is Lot NGEVX108.
The identified hazard is potential packaging defects that may compromise the sterile barrier of the product. The sterile barrier is critical for maintaining product safety and integrity.
The product was distributed nationwide in the United States. A total of 40 units are subject to this recall.
The recalled product
- Product
- Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
- Manufacturer
- C.R. Bard Inc
- Affected units
- 40
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 A943216
- Lot NGEVX108
- UDI (01)00801741100833(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 →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 · sterile barrier defect
See all →- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighPruitt Occlusion Catheter Recalled Due to Incomplete Sterile Barrier Seals
FDA (Devices) · 2025-05-21
- HighPruitt Irrigation Occlusion Catheter Recalled for Incomplete Sterile Seals
FDA (Devices) · 2025-05-21
- HighB Braun Interventional ELITE HV Hemostasis Valve Introducer System Recall
FDA (Devices) · 2025-05-14
- HighSocrates 38 Aspiration Catheter Recall Due to Sterile Barrier Defect
FDA (Devices) · 2025-03-05
Similar recalls
- LowC.R. Bard Recalls SureStep Urine Collection System for Labeling Issues
FDA (Devices) · 2016-08-10
- ModerateBard Medical Recalls SureStep Foley Tray System Due to Leakage Risk
FDA (Devices) · 2019-02-13
- ModerateC.R. Bard Recalls SureStep Foley Tray Systems Due to Residue
FDA (Devices) · 2020-05-20
- HighC.R. Bard Recalls Medical Devices Containing Latex Catheters
FDA (Devices) · 2017-01-18
- HighC.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