Bard SureStep Foley Tray Recall: Packaging Defects Risk Sterile Barrier Failure
C.R. Bard recalls SureStep Foley Trays with potential packaging defects that could compromise sterile barrier. Affected units have specific lot numbers and expiration dates. Consumers should check their product details to determine if recalled.
Lower-risk recall
There is potential for packaging defects that may impact the sterile barrier.
Contact the company
What happened, in plain English
C.R. Bard is recalling SureStep Foley Trays due to potential packaging defects that might compromise the sterile barrier. This could lead to infections if the tray is used without proper sterility. Read more at govinfonow.com/recall/62053-bard-surestep-foley-tray-recall-packaging-defects-risk-sterile-barrier.
Source Summary by GovInfoNow · govinfonow.com/recall/62053-bard-surestep-foley-tray-recall-packaging-defects-risk-sterile-barrier · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2527-2021
Cite this page
“Bard SureStep Foley Tray Recall: Packaging Defects Risk Sterile Barrier Failure.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62053-bard-surestep-foley-tray-recall-packaging-defects-risk-sterile-barrier. Based on FDA recall #Z-2527-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2527-2021%22&limit=1).
Why it’s dangerous
The packaging defects could allow contamination to reach the sterile barrier of the tray. If the sterile barrier is compromised, the tray might not be safe for medical use, increasing infection risk.
Who’s affected
Patients using the SureStep Foley Tray for urinary catheterization are most at risk. Healthcare facilities and individuals who purchased the specific lot numbers are affected.
How to tell if you have this one
Check for lot numbers NGEVX107 (exp. 08/31/2022), NGFR3116 (exp. 02/28/2023), or NGFS1808 (exp. 02/28/2023) on the product label. The product is sold under the SureStep Foley Tray name with specific catalog numbers.
- Brand
Bard- Product
Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock"- Category
Medical device
All 21 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-2521-2021 | Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device; Catalog A119216M; Lots NGFR2561, UDI (01)00801741073687(17)201228(10) and NGFS1312, UDI (01)00801741073687(17)201228(10) | 10,150 units |
| Z-2522-2021 | Catalog A300314A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device; Catalog A300314A, Lot NGFR3627, UDI (01)00801741073724(17)201228(10) | 1760 units |
| Z-2523-2021 | Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device; Catalog A300316A, Lots: NGEVX104 (exp. 08/31/2022), UDI (01)00801741073731(17)201228(10); NGFR3628 (02/28/2023), UDI (01)00801741073731(17)201228(10); GFS1114 (02/28/2023), UDI (01)00801741073731(17)201228(10); and NGFS1166 (02/28/2023), UDI (01)00801741073731(17)201228(10) | 11,780 units |
| Z-2524-2021 | Catalog A300318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device; Catalog A300318A, Lot NGEVX106, UDI (01)00801741073748(17)201228(10) | 350 units |
| Z-2525-2021 | Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device; Catalog A303316A, Lots: NGEVX103 (exp. 08/31/2022), UDI (01)00801741073793(17)201220(10); NGFR3290 (02/28/2023), UDI (01)00801741073793(17)201220(10); NGFR3291 (exp. 02/28/2023), UDI (01)00801741073793(17)201220(10); and NGFR4542 (exp. 02/28/2023) UDI (01)00801741073793(17)201220(10) | 11,600 units |
| Z-2526-2021 | Catalog A303318A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device; Catalog A303318A, Lot NGEVX105, UDI (01)00801741073809(17)201220(10) | 420 units |
| Z-2527-2021 | Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device; Catalog A319416AM, Lots NGEVX107 (exp. 08/31/2022), UDI (01)00801741073861(17)201220(10); NGFR3116 (exp. 02/28/2023), UDI (01)00801741073861(17)201220(10); and NGFS1808 (02/28/2023) UDI (01)00801741073861(17)201220(10) | 5950 units |
| Z-2528-2021 | Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device; Catalog A399400A, Lot NGFR3569, UDI (01)00801741073915(17)201228(10); Lot NGFR2691, UDI (01)00801741073915(17)201228(10) Expanded 10/8/2021 adding Lot NGFR2691, UDI (01)00801741073915(17)201228(10) | 3980 units |
| Z-2529-2021 | Catalog A800061, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray; Catalog A800061, Lot NGFR3658, UDI (01)00801741104848(17)251228(10) | 2660 units |
| Z-2530-2021 | Catalog A800360, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray; Catalog A800360, Lot NGFR3570, UDI (01)00801741073922(17)251228(10) | 1140 units |
| Z-2531-2021 | Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray; Catalog A800361, Lots: NGFR0310, UDI (01)00801741073939(17)201220(10); NGFR0311,UDI N(01)00801741073939(17)201220(10); GFR2807, UDI (01)00801741073939(17)201220(10); NGFR2829, UDI (01)00801741073939(17)201220(10); NGFR3571, UDI (01)00801741073939(17)201220(10); NGFR5475, UDI (01)00801741073939(17)201220(10); nd NGFR5481 UDI (01)00801741073939(17)201220(10) | 33,380 units |
| Z-2532-2021 | Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray; Catalog A800365, Lots: NGFR3131, UDI (01)00801741073960(17)201220(10); NGFR3295, UDI (01)00801741073960(17)201220(10); NGFR4413, UDI (01)00801741073960(17)201220(10); NGFR4599, UDI (01)00801741073960(17)201220(10); and NGFS3150 UDI (01)00801741073960(17)201220(10) | 18,060 units |
| Z-2533-2021 | Catalog A897514, SureStep" Foley Tray, Silicone, Drainage Bag, StatLock" Stabilization Device; Catalog A897514, Lot NGFR2808, UDI (01)00801741104510(17)201228(10) | 1710 units |
| Z-2534-2021 | Catalog A899916, SureStep" Foley Tray, Lubricath", Drainage Bag, StatLock" Stabilization Device; Catalog A899916, Lot NGFR0101, UDI (01)00801741074011(17)251228(10) | 960 units |
| Z-2535-2021 | Catalog A902616, SureStep" Foley Tray, Bardex" I.C., Lubricath", Urine Meter; Catalog A902616, Lot NGFR3277, UDI (01)00801741104633(17)251228(10) | 80 units |
| Z-2536-2021 | Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device; Catalog A902916, Lots: NGFR3115, UDI (01)00801741074073(17)251228(10); NGFR3278, UDI (01)00801741074073(17)251228(10); NGFR3279, UDI (01)00801741074073(17)251228(10); NGFS1308, UDI (01)00801741074073(17)251228(10); NGFS1309, UDI (01)00801741074073(17)251228(10); and NGFS1366, UDI (01)00801741074073(17)251228(10) | 29,890 units |
| Z-2537-2021 | Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device; Catalog A943216, Lot NGEVX108, UDI (01)00801741100833(17)201228(10) | 40 units |
| Z-2538-2021 | Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device; Catalog A319516AM, Lot NGFS1691, UDI (01)00801741073892(17)201228(10); NGFR3282, UDI (01)00801741073892(17)201228(10); and NGFR4423, UDI (01)00801741073892(17)201228(10) Expanded 10/8/2021 adding Lot NGFS1691 UDI (01)00801741073892(17)201228(10) | 8170 units |
| Z-2539-2021 | Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device; Catalog A902416, Lot NGFR4567, UDI (01)00801741074042(17)201228(10) | 4830 units |
| Z-2540-2021 | Catalog A303416A, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing Complete Care", Drainage Bag, StatLock" Stabilization Device; Catalog A303416A, Lot NGFS1844, UDI (01)00801741073823(17)201228(10); NGFS1845, UDI (01)00801741073823(17)201228(10) | 6440 units |
| Z-2541-2021 | Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device; Catalog A942216, Lot NGFS3274, UDI (01)00801741074110(17)201228(10) | 1440 units |
What to do — step by step
Check Product Details
Look for the lot numbers NGEVX107 (exp. 08/31/2022), NGFR3116 (exp. 02/28/2023), or NGFS1808 (exp. 02/28/2023) on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 55 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is there a risk of serious injury from this product?
The recall indicates a potential risk of infection if the sterile barrier is compromised, but the hazard is not described as causing serious injury in normal use.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2527-2021 (August 5, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2527-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.