Foley Catheter Tray Recalled Due to Potential Packaging Defects
C.R. Bard is recalling 2,660 units of SureStep Foley Catheter 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 recall involves a medical device with the potential to compromise sterility and safety. Although no injuries or illnesses have been reported, a compromised sterile barrier on a catheter represents a risk-of-harm product where injury has not yet been reported.
Plain-English summary
C.R. Bard Inc. is recalling 2,660 units of the SureStep Foley Tray with Bard Lubricath Foley Catheter (Catalog A800061, Lot NGFR3658) due to potential packaging defects that may impact the sterile barrier.
The affected units have been distributed nationwide. If you have received this product, contact C.R. Bard Inc. or your healthcare provider for instructions.
The recalled product
- Product
- Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
- Manufacturer
- C.R. Bard Inc
- Affected units
- 2,660
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 A800061
- Lot NGFR3658
- UDI (01)00801741104848(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 →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
- ModerateC.R. Bard Recalls SureStep Foley Tray Systems Due to Residue
FDA (Devices) · 2020-05-20
- 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
- ModerateBard Medical Recalls SureStep Foley Tray System Due to Leakage Risk
FDA (Devices) · 2019-02-13
- HighLubri-Sil Foley trays recalled over inserts describing the wrong catheter material
FDA (Devices) · 2025-09-24
- ModerateBard SureStep Foley Tray System Recalled for Potential Sample Port Leaks
FDA (Devices) · 2019-02-13