C.R. Bard Inc
FDA Regulatory Profile
C.R. Bard Inc appears in FDA public data with 117 recalls — including 5 Class I (most serious) —, 646 510(k) clearances, 23 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2226-2026, Class II) was initiated on April 23, 2026. Its most recent 510(k) clearance was granted on July 10, 2026.
Summary
- Total Recalls
- 117 (5 Class I)
- 510(k) Clearances
- 646
- Inspections
- 23
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2226-2026 | Class II | Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 3342 | April 23, 2026 |
| Z-0907-2026 | Class II | BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630 | November 6, 2025 |
| Z-0905-2026 | Class II | Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614 | November 6, 2025 |
| Z-0908-2026 | Class II | BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm, Ureteral Stent Kit REF 78826 | November 6, 2025 |
| Z-0906-2026 | Class II | BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426 | November 6, 2025 |
| Z-2589-2025 | Class II | SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A30 | July 17, 2025 |
| Z-2590-2025 | Class II | SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: | July 17, 2025 |
| Z-2591-2025 | Class II | SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216 | July 17, 2025 |
| Z-2462-2025 | Class II | Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Cathe | June 18, 2025 |
| Z-2076-2025 | Class II | REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra | June 3, 2025 |
| Z-2075-2025 | Class II | BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - | June 3, 2025 |
| Z-2074-2025 | Class II | BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr | June 3, 2025 |
| Z-1755-2025 | Class I | Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Lengt | April 17, 2025 |
| Z-1758-2025 | Class I | Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300 | April 17, 2025 |
| Z-1756-2025 | Class I | Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100 | April 17, 2025 |
| Z-1759-2025 | Class I | Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740 | April 17, 2025 |
| Z-1757-2025 | Class I | Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110 | April 17, 2025 |
| Z-2154-2024 | Class II | Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Comp | May 9, 2024 |
| Z-0798-2024 | Class II | Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN004 | December 20, 2023 |
| Z-0801-2024 | Class II | Bard¿ Lopez Valve¿ with ENFit, REF EN0056000 | December 20, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253514 | Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Naso | July 10, 2026 |
| K254076 | BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit | May 29, 2026 |
| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Acc | March 17, 2026 |
| K251864 | Rubber Utility Catheter | February 23, 2026 |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) | May 15, 2025 |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. | January 31, 2025 |
| K230356 | Aspirex Thrombectomy System | March 31, 2023 |
| K223177 | Highlander 014 PTA Balloon Dilatation Catheter | January 20, 2023 |
| K222793 | WavelinQ Generator | October 17, 2022 |
| K220270 | Aspirex Thrombectomy System | June 21, 2022 |
| K213203 | Provena(TM) Midline Catheter | May 13, 2022 |
| K212588 | Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Cathete | May 4, 2022 |
| K212708 | Halo One Thin-Walled Guiding Sheath | September 23, 2021 |
| K211738 | Rotarex Atherectomy System | September 14, 2021 |
| K203363 | Crosser iQ CTO Recanalization System | August 12, 2021 |
| K203575 | GlidePath Retro Long-Term Hemodialysis Catheter | July 1, 2021 |
| K201452 | Groshong NXT PICC Catheter | March 12, 2021 |
| K203275 | Recon Support Catheter | March 1, 2021 |
| K202150 | GlidePath 7.5F Long-Term Dialysis Catheter | November 18, 2020 |
| K200818 | 3DMax MID Anatomical Mesh | July 17, 2020 |