Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand Foley Cath

FDA device recall Z-2226-2026 · posted 2026-05-21 · Open, Classified

Recall details

Recalling firm

C.R. Bard Inc

Reason for recall

Due to stain present on the surface of affected foley catheters.

Action taken

On 04/23/2026, the firm sent via region courier services "URGENT Medical Device Recall" Letters informing customers that BD has received complaints, and confirmed through internal inspection that stains are present on the surface of the affected silastic catheters. The cause of the stains was determined to be an increased amount of a raw material used in the manufacturing process. This raw material may be harmful if present in increased amounts on the surface of the catheter. Customers are instructed to: 1. Immediately Discontinue Use 2. Please check all inventory locations within your institution for the Bard Silastic Foley Catheters listed in Attachment 2. 3. Immediately quarantine and destroy all devices within your facility s control per your facility s procedures. 4. Share this notice with any users of the product within your facilities to ensure they are also aware of this Medical Device Correction. 5. If you have purchased this product through a distributor, please contact this distributor to request appropriate credit. 6. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the correction notification, whether or not you have any affected product, so that BD may confirm your receipt of this notification and provide credit. For Questions: Product Use Inquiries - 1-800-555-7422 option #2 available 24hours/7 days per week Product Complaints, Technical Support - 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaint when prompted M-F 8am - 5pm CT or Email: productcomplaints@bd.com

Root cause

Material/Component Contamination

Status

Open, Classified

Product code

EZL

Quantity affected

106,160

Distribution

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

Date initiated

2026-04-23

Date posted

2026-05-21

Location

Covington, GA

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