C.R. Bard Foley Catheter Kits Recalled for Potential Sterile Barrier Defects
C.R. Bard is recalling 960 units of Foley Tray catheter kits (lot NGFR0101) due to potential packaging defects that may compromise the sterile barrier.
What this means for you
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 Class II recall of a medical device designed for direct patient contact (Foley catheter system). The hazard—potential packaging defects that may compromise sterile barrier—represents a risk of patient harm through contamination. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).
Plain-English summary
C.R. Bard Inc. is recalling 960 units of the Catalog A899916 SureStep Foley Tray, which includes Lubricath Drainage Bag and StatLock Stabilization Device. The affected lot is NGFR0101 (UDI: 00801741074011, expiration date 12/28/2025). These units were distributed nationwide across the United States.
The recall was initiated due to potential packaging defects that may impact the sterile barrier of the product.
The FDA classified this as a Class II recall.
The recalled product
- Product
- Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device
- Manufacturer
- C.R. Bard Inc
- Category
- Medical Device — Catheter Kit
- Hazard
- packaging-defect
- sterile-barrier-defect
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 A899916
- Lot NGFR0101
- UDI (01)00801741074011(17)251228(10)
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03