Recall Z-2226-2026 ยท EZL Catheter, Retention Type, Balloon
C.R. Bard Inc
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
| Date | May 21, 2026 (initiated Apr 23, 2026) |
| Status | Open, Classified |
| Reason | Due to stain present on the surface of affected foley catheters. |
| Root cause | Material/Component Contamination |
| Action | 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 instit |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951103 | SILASTIC BRAND FOLEY CATHETER C.R. Bard, Inc., Apr 28, 1995 |