510(k) · Cleared
Recalled · Class II · 2026Bardex, Lubri-Sil and Lubri-Sil IC All-Silicone Foley Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · EZL Catheter, Retention Type, Balloon
Cleared on May 14, 2004 after a 77-day review. The FDA summary names its predicate without a number. It has been recalled 5 times.
- Decided
- May 14, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- EZL
- Recalls
- 5
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EZL device
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- #2 Held for the reportin the report
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What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Bardex® All-Silicone Foley Catheter Named without a submission number | |
| * | — | Lubri-Sil® All-Silicone Foley Catheter Named without a submission number | |
| * | — | Lubri-Sil® All-Silicone I.C. Foley Catheter Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2026 | Class II | Z-3115-2026 | Under Investigation by firm | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. |
| Aug 5, 2021 | Class II | Z-2540-2021 | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. |
| Aug 5, 2021 | Class II | Z-2541-2021 | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. |
| Aug 5, 2021 | Class II | Z-2537-2021 | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. |
| Aug 5, 2021 | Class II | Z-2539-2021 | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All EZL devicesEZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EZL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EZL
123in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EZL
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · EZL
1,381in 2025
MAUDE reports naming product code EZL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 186 | 0 | 8 |
| 2008 | 2 | — | 0 | 6 |
| 2009 | 4 | 114 | 0 | 6 |
| 2010 | 1 | — | 0 | 27 |
| 2011 | 2 | — | 0 | 79 |
| 2012 | 0 | — | 0 | 65 |
| 2013 | 3 | 151 | 0 | 99 |
| 2014 | 2 | — | 0 | 229 |
| 2015 | 3 | 132 | 0 | 303 |
| 2016 | 1 | — | 0 | 326 |
| 2017 | 2 | — | 0 | 571 |
| 2018 | 9 | 177 | 0 | 677 |
| 2019 | 3 | 266 | 1 | 671 |
| 2020 | 4 | 137 | 0 | 712 |
| 2021 | 2 | — | 0 | 702 |
| 2022 | 2 | — | 0 | 884 |
| 2023 | 3 | 282 | 2 (2) | 772 |
| 2024 | 5 | 123 | 2 | 1,029 |
| 2025 | 1 | — | 0 | 1,381 |
| 2026 | 4 | 170 | 2 | — |
What is it indicated for?
The Bardex®, Lubri-Sil® and Lubri-Sil® I.C. All-Silicone Foley Catheters are indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040504: Bardex, Lubri-Sil and Lubri-Sil IC All-Silicone Foley Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040504
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026