C.R. Bard Foley Catheter Care Kits Recalled for Potential Sterile Barrier Defect
C.R. Bard Inc is recalling Foley catheter care kits (catalog A303416A) because potential packaging defects could compromise the sterile barrier. Approximately 6,440 units were 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: This is a potential risk-of-harm medical device where no illnesses or injuries have been reported. The sterile barrier defect is a theoretical hazard that could result in product contamination, warranting a High severity rating per FDA Class II guidelines without confirmed adverse events.
Plain-English summary
C.R. Bard Inc is recalling certain Foley catheter care kits due to potential packaging defects that may compromise the sterile barrier. The affected product is catalog number A303416A (SureStep Foley Tray, Lubri-Sil I.C., Temperature Sensing Complete Care Drainage Bag, StatLock Stabilization Device), with lot numbers NGFS1844 and NGFS1845.
Approximately 6,440 units of this product were distributed nationwide throughout the United States. A packaging defect has the potential to affect the sterile barrier integrity of the product.
The recalled product
- Product
- Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device
- Manufacturer
- C.R. Bard Inc
- Affected units
- 6,440
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 (4)
- Catalog A303416A
- Lot NGFS1844
- UDI (01)00801741073823(17)201228(10)
- NGFS1845
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
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See all →- High
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- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
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- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
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Similar recalls
- HighC.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
- HighBard Foley Catheter Trays Recalled for Temperature Display Malfunction
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- HighBard Foley procedural trays recalled due to incomplete sterile seals
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- SevereCustomed Recalls Foley Catheter Kits Due to Packaging Integrity Concerns
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- HighC.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
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- SevereCustomed Recalls Foley Catheter Kits Due to Potential Packaging Integrity Issues
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