Recall Z-3115-2026 ยท EZL Catheter, Retention Type, Balloon
C.R. Bard Inc
Products that contain the Pericare Wipes: Bard Foley Tray With Lubri-Sil All-Silicone Foley Catheter REF: 947314 947316 947318 UDI codes: 00801741024924 10801741024921 00801741024931 10801741024938 00801741024948 10801741024945 Lubri-Sil I.C. Complete Care All-Silicone Foley Catheter Tray REF: 300416A UDI code: 00801741024580 10801741024587 SureStep" Foley Tray System Lubri-Sil IC Complete Car
| Date | Sep 4, 2026 (initiated Jun 25, 2026) |
| Status | Open, Classified |
| Reason | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. |
| Root cause | Under Investigation by firm |
| Action | On 06/25/2026, an "URGENT Medical Device Recall" Letter was via regional courier services or other electronic means to inform customers that based on customer feedback, BD has identified that the CliniClean Pericare Wipes provided within Urinary Catheter Trays may be potentially contaminated with an unknown non-biological substance. Customer are instructed to: Do not use CliniClean Pericare Wipes contained within the affected products listed in Attachment 2. The CliniClean Pericare Wipes are the only impacted component within the tray and all remaining components can continue to be safely use |
| Quantity | 283883 trays/kits |
| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WY. The countries of Bahrain, Canada, Cos |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040504 | BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS C.R. Bard, Inc., May 14, 2004 |
| K070508 | BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR C.R. Bard, Inc., Mar 9, 2007 |
| K070582 | BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS C.R. Bard, Inc., Dec 7, 2007 |
| K984084 | BARDEX LUBRI-SIL FOLEY CATHETER Bard Medical Div., Feb 1, 1999 |