SureStep Foley Catheter Tray Recalled for Packaging Defects
C.R. Bard is recalling 18,060 units of SureStep 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 for potential packaging defect with no reported illnesses or injuries. Per severity rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
C.R. Bard Inc. is recalling the SureStep Foley Catheter Tray (Catalog A800365) due to potential packaging defects. Approximately 18,060 units have been distributed nationwide across five affected lots: NGFR3131, NGFR3295, NGFR4413, NGFR4599, and NGFS3150.
The defect involves the packaging's ability to maintain sterility. While no illnesses or injuries have been reported to date, a compromised sterile barrier could potentially allow contamination of the catheter tray.
Healthcare providers, distributors, and facilities that have received this product should verify their inventory against the affected lot numbers and UDI codes provided. Contact C.R. Bard for information regarding affected inventory in your possession.
The recalled product
- Product
- Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
- Manufacturer
- C.R. Bard Inc
- Affected units
- 18,060
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 (7)
- Catalog A800365
- Lots: NGFR3131
- UDI (01)00801741073960(17)201220(10)
- NGFR3295
- NGFR4413
- NGFR4599
- and NGFS3150 UDI (01)00801741073960(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
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FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
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Similar recalls
- 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 Foley Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- HighLubri-Sil Foley trays recalled over inserts describing the wrong catheter material
FDA (Devices) · 2025-09-24
- ModerateBard Medical Recalls SureStep Foley Tray System Due to Leakage Risk
FDA (Devices) · 2019-02-13
- ModerateBard SureStep Foley Tray System Recalled for Potential Sample Port Leaks
FDA (Devices) · 2019-02-13