Device recall: SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A
Class II FDA enforcement event 97273. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Class II, in the words of FDA
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
C.R. Bard Inc started this device recall on 17 Jul 2025. The firm address in the FDA record is in Covington, GA. FDA put the recall in Class II. FDA event 97273 has 3 product records. The first FDA enforcement report date is 24 Sep 2025. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.
Recalling firm
C.R. Bard Inc, Covington, GA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2589-2025 | SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316A | 4,300 | Class II | Ongoing | 24 Sep 2025 |
| Z-2590-2025 | SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A | 4,300 | Class II | Ongoing | 24 Sep 2025 |
| Z-2591-2025 | SureStep Foley Tray System BARD Lubri-Sil Foley Catheter Tray, REF: A942216 | 3670 | Class II | Ongoing | 24 Sep 2025 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2025
- 945
- Share of these events in Class II
- 85%
- Product records in this event
- 3Median of the firm: 1
- Events of the firm on the register
- 49
Other events of the firm
Official channels
- FDA enforcement report Z-2589-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 97273. https://recallregister.com/fda/ii/97273/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution including in the states of NC, FL, NY, MA, MN, TX, CA, OH, MI, WA, NJ, IL, ID, SC, IN, OK, OR, AL, VA, HI, MO, MS, MD, AZ, KY, GA, IA, CO, NM, PA, ME, UT, NE.
- What quantity of product is in FDA event 97273?
- The event has 3 product records. The first record gives this quantity:
4,300
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2025 have the same class?
- 85% of the 945 device events that started in 2025 are in Class II.