SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414A

Recall Insight

This FDA Devices action (record #Z-2590-2025) was formally reported on September 24, 2025, with the manufacturer initiating the action on July 17, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. C.R. Bard Inc is listed as the recalling firm, operating out of Covington, GA. Federal records indicate 4,300 units are affected.

The documented reason for this recall is: 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, o… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.