FDA Medical devices recall ·
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray recall
- Recall number
- Z-2591-2025
- Date
- (initiated July 17, 2025)
- Company / brand
- C.R. Bard Inc
8195 Industrial Blvd Ne, Covington, GA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3670
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216
Why was it recalled?
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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# NGJX4320
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.
States: Alabama Arizona California Colorado Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kentucky Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi North Carolina Nebraska New Jersey New Mexico New York Ohio Oklahoma Oregon Pennsylvania South Carolina Texas Utah Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2591-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.