FDA-Device2026-05-27Class IIPACKAGING DEFECT
C.R. Bard Silastic Foley Catheters recalled for surface staining
C.R. Bard Silastic Foley Catheters recalled for surface stain
C.R. Bard has recalled certain Silastic Brand Foley Catheters (5cc and 30cc models) due to staining on the catheter surface. The affected catheters were distributed across the U.S. and Canada.
- Check if your Foley catheter matches one of the affected catalog numbers (33416, 33418, 33420, 33422, 33424, 33614, 33616, 33618, 33620, 33622, 33624) and lot numbers listed in the recall.
- Contact your healthcare provider or medical supplier if you have an affected catheter.
- Do not use affected catheters without consulting your healthcare provider.
Hazard
Due to stain present on the surface of affected foley catheters.
Sold states
U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, and WI O.U.S.: Canada
Affected count
106,160
Manufactured in
8195 Industrial Blvd Ne, Covington, GA, United States
Products
Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Catheter 5cc REF: 33614 33616 33618 33620 33622 33624
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2226-2026Don't want to check this manually?
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